T c: T c2 Intake, Review and Approval of Industry ... · Approval Signature: Typed Name and T1 e: Intake, Review and Approval of Industry-Sponsored Human Subjects Research Byrne T

"\\}Wake Forest· Baptist Med cal Center

Approval Signature:

Typed Name and T1 e:

Intake, Review and Approval of Industry-Sponsored Human

Subjects Research

Byrne

T c: Policy/SOP Number: Original Effective Date: Current

Date:

Contact:

Date of Si nature:

T c2

03.005.0CR-P-OI

April 01 , 2018

Office of Clinical Research - CTSI

February 15, 2018

t & Associate Dean, Research Administration and Operations

l. General Statement This purpose of this policy is to ensure that all required reviews and approvals related to the regulatory, operational, and financial aspects of industry-sponsored human subjects research are obtained prior to study activation at Wake Forest Baptist Medical Center (WFBMC). a) Scope: All WFBMC employees, faculty and staff involved with industry-sponsored human

subjects research are responsible for complying with this policy. b) Responsible Department/Parties

i. Polley Owner: Clinical and Translational Science Institute (CTSI) ii. Procedure: Office of Clinical Research- CTSI iii. Supervision: Office of Clinical Research- CTSI iv. Implementation: Office of Clinical Research- CTSI

2. Definitions: a) Centers for Medicare and Medicaid Services (CMS): CMS is an agency within the Department of

Health and Human Services (HHS). CMS has authority over the two largest Federal healthcare programs, Medicare and Medicaid under unified leadership.

b) CRMS: The previous enterprise clinical research management system for WFBMC replaced with WISER.

c) Confidential Disclosure Agreement (COAl: A legal contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties. It is a contract through which the parties agree not to disclose information covered by the agreement. A CDA creates a confidential relationship between the parties to protect any type of confidential and proprietary information or trade secrets. As such, a CDA protects non-public business information. Also known as a non-disclosure agreement (NDA), confidentiality agreement (CA), proprietary information agreement (PIA), or secrecy agreement.

d) Coverage Analysis: A systematic review of all procedures listed in the study protocol's schedule of events to determine which ones are 'billable' and where these services should be billed. Coverage Analysis is a required process for all human subjects research in which tests, procedures, and interventions associated with the study are planned to be invoiced to third party payers (the participant's insurance or the participating WFBMC patient (if they have no insurance)).

e) efRB: A commercial based software licensed from Click Commerce. The software was

introduced at Wake Forest in 2006, and has been highly customized to fit the needs of the institution.

f) Electronic Medical Record (EMR): The record of a subject’s past and present health care related encounters and activities at WFBMC and/or affiliates. The system is licensed by EPIC and its internal name is “WakeOne”.

g) InfoEd: The system used by 1) study teams for proposal development, routing to OSP and system-to-system submission to external funding sources; 2) study teams to route contract and other required routing documents to the Office of Sponsored Programs (OSP) 2) by study teams to track and review timeline information on contract negotiations, contract execution, and chartfield setup process for industry sponsored research-related agreements, 3) by OSP contracts group as a contract negotiation management system, and 5) OSP for reporting and development of metrics related to industry supported contracts.

h) RSH Record: The research administration demographic record for a study in EPIC (WakeOne).

i) WFBMC: Wake Forest Baptist Medical Center and all affiliated organizations including Wake Forest University Health Sciences (WFUHS), North Carolina Baptist Hospital (NCBH), and all on-site and off-site subsidiaries governed by WFBMC policies and procedures.

j) WakeOne: The record of all of a subject’s past and present health care related encounters and activities at WFBMC and/or affiliates. The system is licensed by EPIC and its internal name is “WakeOne”.

k) WISER: Wake Integrated Solution for Enterprise Research. The enterprise clinical research management system for WFBMC replacing CRMS, implemented in calendar year 2017.

3. Guidelines

a) Feasibility of Industry-Sponsored Human Subjects Research

i. All industry-sponsored human subjects research anticipated to be performed at WFBMC

should be evaluated for feasibility by the Principal Investigator or Designee before the study

is submitted for review by CTSI. See the SOP titled “Study Feasibility for Industry-Sponsored

Human Subjects Research” (OCR-S-01-03) for more details.

b) All Confidential Disclosure Agreements (CDAs) received from industry sponsors/clinical research

organizations must be submitted to the Office of Sponsored Programs Contracts group for

review and negotiation.

c) Intake of Industry-Sponsored Human Subjects Research


must be submitted for review in the following three (3) systems:

1. InfoEd: For receipt of the clinical trial agreement by the Office of Sponsored Programs.

2. WISER: For receipt of the proposed sponsor budget by the Office of Clinical Research

Study Administration team.

3. eIRB: For receipt of all regulatory items by the WFUHS Institutional Review Board.

d) Review of Industry-Sponsored Human Subjects Research

i. The Office of Sponsored Programs (OSP) will negotiate all terms and conditions for all

Clinical Trial Agreements related to WFBMC industry-sponsored human subjects research.

ii. The Office of Clinical Research (OCR) will develop the study calendar, coverage analysis (as

applicable), and budget for all WFBMC industry-sponsored human subjects research in

WISER. The budget developed in WISER will provide appropriate procedural and institutional

costs that should be negotiated into the sponsor budget by the Principal Investigator or

Designee. The Principal Investigator or Designee is responsible for review and approval of

the study calendar, coverage analysis and budget built in WISER by the OCR Study

Administration team.

iii. The WFUHS Institutional Review Board (IRB) will review each human subjects research study

to ensure that it meets the regulatory criteria for approval.

e) Approval of Industry-Sponsored Human Subjects Research

i. Once all regulatory-related concerns are addressed, the WFUHS IRB will provide a letter

documenting IRB Approval.

ii. Upon completion of the negotiation of the clinical trial agreement, a securing of WFUHS IRB

approval, and confirmation that the financial exhibit in the agreement aligns to the WISER

budget, OSP will secure full execution of the document and work to complete the process of

creating a study chartfield.

iii. Once the sponsor budget is aligned to the budget in WISER and there is assurance that all

study costs will be covered, the IRB has approved the study, and the agreement is fully

executed, the OCR will work to activate the study in WISER and generate the RSH record for

the study in WakeOne.

4. Review/Revision/Implementation

This policy shall be reviewed at least every three (3) years from the effective date.

5. Related Policies and Standard Operating Procedures

System Access for Industry-Sponsored Human Subjects Research (OCR-S-01-01)

Study Feasibility for Industry-Sponsored Human Subjects Research (OCR-S-01-02)

Research Intake for Industry-Sponsored Human Subjects Research (OCR-S-01-03)

Study Start-Up for Industry-Sponsored Human Subjects Research (OCR-S-01-04)

Budget Development and Negotiation for Industry-Sponsored Human Subjects Research (OCR-S-

01-05)

Site Initiation Visits for Industry-Sponsored Human Subjects Research (OCR-S-01-06)

6. Regulations: N/A

7. Revision Dates

Type: Tier 3 Standard

System Access for Industry- Operatin~ Procedure

\..'\).Wake Forest· Sponsored Human Subjects SOP Number: OCR·S·Ol-01

Baptist Medical Center Research Original April 01, 2018 Effective Date: Current

_(_Revised) Date:

Contact: Office of Clinical Research - CTSI

Approval Signature~ Date of January 18,2018 Si~nature:

Typed Name and Title: Christopher O'Byrne Vice President & Associate Dean, Research Administration and Operations

1. General Purpose/Guideline Statement This Standard Operating Procedure (SOP) is intended to define the process to obtain access to research systems related to industry-sponsored human subjects research to be conducted at Wake Forest Baptist Medical Center (WFBCMC).

a) Scope: All WFBMC employees, faculty and staff involved in industry-sponsored human subjects research.

b) Responsible Department/Parties: i. Procedure Owner: Clinical and Translational Science Institute (CTSI) ii. Procedure: Office of Clinical Research- CTSI iii. Supervision: Office of Clinical Research- CTSI iv. Implementation: Office of Clinical Research- CTSI

2. Definitions: a) Electronic Medical Record (EMR): The record of all of a subject's past and present health care

related encounters and activities at WFBMC and/or affiliates. The system is licensed by EPIC and its internal name is "WakeOne".

b) eiRB: A commercial based software licensed from Click Commerce. The software was introduced at Wake Forest in 2006, and has been highly customized to fit the needs of the institution.

c) Guideline: A process or method for accomplishing a specific task or objective. All guidelines must comply with applicable WFBMC policies and procedures.

d) lnfoEd: The system used by 1) study teams for proposal development, routing to OSP and system·to-system submission to external funding sources; 2) study teams to route contract and other required routing documents to the Office of Sponsored Programs (OSP) 2} by study teams to track and review timeline information on contract negotiations, contract execution, and chartfield setup process for Industry sponsored research-related agreements, 3) by OSP contracts group as a contract negotiation management system, and 5) OSP for reporting and development of metrics related to industry supported contracts.

e) Institutional Review Board (IRB): The federally mandated committee charged with reviewing all

proposed human subjects' research to protect the rights and welfare of the research

participants.

f) PeopleSoft ERP: This system is used to create requisitions or request for payments, review grants information, view award and subcontract files, research invoice payments and various reporting and queries of financial activity. It is suggested that you review the following website to assist in your use of the ERP site: http://intranet.wakehealth.edu/Departments/PeopleSoft-Merger/Finance/.

g) PeopleSoft HCM: This system is used to enter, review and approve HR actions, generate reports and access Effort Reporting. Many helpful tips on how to use HCM can be found on the following HR website: http://intranet.wakehealth.edu/Departments/Human-Resources/How-Tos/Manager-How-Tos.htm.

h) PeopleSoft Report2Web: The online system used to access your PeopleSoft Departmental Financial Reports. In order to best use these reports it is suggested that you review the Financial Reporting Guide (http://intranet.wakehealth.edu/Departments/PeopleSoft-Merger/Documents/Financial-Reporting-Guide--8-1-14-(rev-08-14-2014)-rev-a.htm) and the Report2Web User Guide (http://intranet.wakehealth.edu/Tools/Software/R2W-User-Guide.htm).

i) WFBMC: Wake Forest Baptist Medical Center and all affiliated organizations including Wake Forest University Health Sciences (WFUHS), North Carolina Baptist Hospital (NCBH), and all on-site and off-site subsidiaries governed by WFBMC policies and procedures.

j) WISER: Wake Integrated Solution for Enterprise Research. The enterprise clinical research management system for WFBMC replacing CRMS, implemented in calendar year 2017.

3. Procedure/Guidelines

There are a number of research systems that must be accessed as it relates to conducting industry-

sponsored human subjects research at Wake Forest Baptist Medical Center. Provided below is the

name of each system and how access to each can be obtained.

I. Access to InfoEd

All clinical trial agreements received from sponsors should be submitted to the Office of

Sponsored Programs via InfoEd for review and negotiation. Study teams can use InfoEd to track

the progress of their clinical trial agreement throughout the review, negotiation and signature

process. Submission of the study materials is an essential component of setting up the record in

the institutional financial system and receiving a study chartfield. To obtain access to InfoEd

study teams should contact the Office of Sponsored Programs.

II. Access to WISER

All budgets received from sponsors should be submitted to the Office of Clinical Research via

WISER for review and development. WISER can be used to manage the financial aspects of the

study (track activities completed, track participant activity, track money received and

outstanding, etc.) as well as data (electronic data repository for investigator-initiated trials with

no EDC). To obtain access to WISER, a ITS Service Desk ticket should be submitted detailing the

http://intranet.wakehealth.edu/Departments/PeopleSoft-Merger/Finance/

http://intranet.wakehealth.edu/Departments/PeopleSoft-Merger/Finance/

http://intranet.wakehealth.edu/Departments/Human-Resources/How-Tos/Manager-How-Tos.htm

http://intranet.wakehealth.edu/Departments/Human-Resources/How-Tos/Manager-How-Tos.htm

http://intranet.wakehealth.edu/Departments/PeopleSoft-Merger/Documents/Financial-Reporting-Guide--8-1-14-(rev-08-14-2014)-rev-a.htm

http://intranet.wakehealth.edu/Departments/PeopleSoft-Merger/Documents/Financial-Reporting-Guide--8-1-14-(rev-08-14-2014)-rev-a.htm

http://intranet.wakehealth.edu/Tools/Software/R2W-User-Guide.htm

http://intranet.wakehealth.edu/Tools/Software/R2W-User-Guide.htm

WFBMC personnel needing access and the role(s) needed for that individual. It is strongly

recommended to partake in WISER training. Contact Jim Lineberger ([email protected])

for training information.

III. Access to eIRB

The eIRB software solution is used for both submission and review of study protocols, consent

forms, and other applicable documents. Continuing reviews, amendments, and safety events

are also submitted using the same software. User access is role based and study specific. This

mechanism was designed to protect proprietary information that may be contained in study

documents, and assure that only appropriately trained study personnel would have access to

study documents and be permitted to work on the study.

The software utilizes active directory features, therefore usernames and passwords are

consistent with the institution, and updated regularly according to institutional standards. Users

may request access or different roles through the FAQ feature, and user guides and tutorials are

available online to assist study teams with the completion of the online forms. The “Request

User Roles” function only works if the account has already been activated; so a person who

already has access can request roles (for themselves or others) but a person who does not yet

have eIRB access cannot. A person who needs their account activated will need to contact the

IRB directly either by phone or email. Users are required to complete CITI training prior to

approval of a study, but completion of the training is not required to gain access to the

software.

IV. Access to WakeOne

All WFBMC patients that participate in any WFBMC human subjects research studies should be

linked to the study in WakeOne by a member of the study team, unless an exception is granted

(see Documentation in the Medical Record for Human Subjects Research policy for more

details). To obtain access to WakeOne for research purposes, training must be completed. Here

is some helpful information as it relates to training WakeOne Training needs:

Registration for the “Research Study Coordinators” class is performed through the

Enterprise Learning Management (ELM) System.

o Intranet Home Page → Click on the “HR” tab → select the “PeopleSoft” quick

link on the left → click on “Enterprise Learning Management (ELM) System”

o Select “Find Learning” → “Request New Learning”

o Search Research to find the available Research Study Coordinators classes

available

o Find the Research Study Coordinators class that you would like to attend and

select “Enroll”.

To contact WakeOne Training to request a class that you cannot find in the ELM or to

request training for a user that does not have a typical role you can submit a WakeOne

Training Request Form.

mailto:[email protected]

http://intranet.wakehealth.edu/Departments/WakeOne/Training-Resources/WakeOne-Training-Request-Form.htm

http://intranet.wakehealth.edu/Departments/WakeOne/Training-Resources/WakeOne-Training-Request-Form.htm

If there are questions about WakeOne classes or schedules, call 716-9663. This is also the

phone number to call for updates regarding possible class delays and/or cancellations.

To email WakeOne training: [email protected]

Questions regarding WakeOne access are to be directed to the Help Desk so they can route

a ticket to WakeOne Security. It can take up to 2 business days after a learner has

completed all their required training to have access to WakeOne.

V. Access to PeopleSoft

Study teams should diligently review the post award status of their research projects in

PeopleSoft to account for the revenue received for work performed and the expenses incurred

to carry out the research. Access to PeopleSoft is governed by Information Technology Services.

A PeopleSoft Security Authorization Form must be completed to initiate the access request

process. More details on this process can be found here:

http://intranet.wakehealth.edu/Leadership/Leadership-Updates/2015/New-Form-for-

Requesting-PeopleSoft-Security-Access.htm

For access to Report2Web, the helpdesk should be contacted at 6-4357.


This operational guideline shall be reviewed at least every three (3) years from the effective date.

5. Related Governing (Tier Level) Policies and Standard Operating Procedures

Intake, Review, and Approval of Industry-Sponsored Human Subjects Research (03.005.OCR-P-

01)



Study Start-Up for Industry-Sponsored Human Subjects Research (OCR-01-04)


01-05)

Site Initiation Visit for Industry-Sponsored Human Subjects Research (OCR-S-01-06)

6. Revision Dates

mailto:[email protected]

http://intranet.wakehealth.edu/Leadership/Leadership-Updates/2015/New-Form-for-Requesting-PeopleSoft-Security-Access.htm

http://intranet.wakehealth.edu/Leadership/Leadership-Updates/2015/New-Form-for-Requesting-PeopleSoft-Security-Access.htm


I Opcratinl! Procedure

\'\.).Wake Forest· Research Intake for Industry- SOP Number: OCR-S-O I -02 Original Baptist Med1cal Center Sponsored Human Subjects Effective Date:

April 01,2018

Research Current _(_Revised) Date:

Contact: Office of Clinical ....., Research - CTSI

Approval Signature:~- Date of February 15, 2018

Shtnature:

Typed Name and Tiil'C:' Christopher O'Byrne Vice President & Associate Dean, Research Administration and Operations

1. General Procedure/Guideline Statement:

This Standard Operating Procedure (SOP) is intended to outline the administrative processes and

documents required to notify Wake Forest Baptist Medical Center (WFBMC) central parties of a

potential human subjects research study.

a) Scope: All WFBMC employees, faculty and staff involved with human subjects research are responsible for complying with this SOP.

b) Responsible Department/Parties: i. Procedure Owner: Clinical and Translational Science Institute (CTSI) ii. Procedure: Office of Clinical Research- CTSI iii. Supervision: Office of Clinical Research - CTSI iv. Implementation: Office of Clinical Research- CTSI

2. Definitions: a) Budget: A detailed statement outlining estimated project costs to support the sponsored

project. A budget should include all the Direct Costs and Facilities and Administrative (F&A) (or overhead/indirect) costs required to carry out the project objectives.

b) Clinical Trial Agreement: The written agreement or contract between the study sponsor (or Contract Research Organization working on behalf of the sponsor) and WFBMC. This document contains information (exhibits or attachments) including the study budget

c) Confidential Disclosure Agreement (COA): A legal contract between at least two parties that

outlines confidential material, knowledge, or information that the parties wish to share with

one another for certain purposes, but wish to restrict access to or by third parties. It is a

contract through which the parties agree not to disclose information covered by the

agreement. A CDA creates a confidential relationship between the parties to protect any

type of confidential and proprietary information or trade secrets. As such, a CDA protects

non-public business information. Also known as a non-disclosure agreement (NDA),

confidentiality agreement (CA), proprietary information agreement (PIA), or secrecy

agreement.

d) Coverage Analysis: A systematic review of all procedures listed in the study protocol's

schedule of events to determine which ones are 'billable' and where these services should

be billed. Coverage Analysis is a required process for all human subjects research in which

tests, procedures, and interventions associated with the study are planned to be invoiced to

third party payers (the participant’s insurance of the participating WFBMC patient (if they

have no insurance).

e) eIRB: The online protocol submission and review system for the Wake Forest University

Health Sciences Institutional Review Board (IRB). The eIRB provides a collaboration

workspace for the IRB and the Human Subjects Research community and is the location for

IRB review activities.

f) Electronic Medical Record (EMR): The record of all of a subject’s past and present health

care related encounters and activities at WFBMC and/or affiliates. The system is licensed by

EPIC and its internal name is “WakeOne”.

g) InfoEd: The system used by 1) study teams for proposal development, routing to OSP and

system-to-system submission to external funding sources; 2) study teams to route contract

and other required routing documents to the Office of Sponsored Programs (OSP) 2) by

study teams to track and review timeline information on contract negotiations, contract

execution, and chartfield setup process for industry sponsored research-related

agreements, 3) by OSP contracts group as a contract negotiation management system, and

5) OSP for reporting and development of metrics related to industry supported contracts.

h) WFBMC: Wake Forest Baptist Medical Center and all affiliated organizations including Wake

Forest University Health Sciences (WFUHS), North Carolina Baptist Hospital (NCBH), and all

on-site and off-site subsidiaries governed by WFBMC policies and procedures.

i) WISER: Wake Integrated Solution for Enterprise Research is the enterprise clinical research

management system for WFBMC. It replaced CRMS in calendar year 2017.

3. Procedure/Guidelines:

a) Feasibility of Industry-Sponsored Human Subjects Research


should be evaluated for feasibility by the Principal Investigator or Designee before the

study is submitted for intake, review and approval by CTSI. See the SOP titled “Study

Feasibility for Industry-Sponsored Human Subjects Research” (OCR-S-01-03) for more

details.

ii. If the study population is intended to be Wake Forest Baptist Health patients, it is

strongly recommended that the study team work with the CTSI Recruitment Unit to

perform a Translational Data Warehouse query to assess how many potential

participants there would be available in the WFBMC population to enroll for this study.

b) All Confidential Disclosure Agreements (CDAs) received from industry sponsors/clinical

research organizations must be submitted to the Office of Sponsored Programs Contracts

group for review, negotiation and execution.

c) Intake of Industry-Sponsored Human Subjects Research

i. All industry-sponsored human subjects research evaluated for feasibility and anticipated to

be performed at WFBMC must be submitted for review in the following three (3) systems:

1. InfoEd (http://infoed.wakehealth.edu/): For receipt of the clinical trial agreement by the

Office of Sponsored Programs (OSP).

i. The draft clinical trial agreement received from the sponsor must be uploaded into

this system.

ii. The OSP Contracts Officer will communicate to the PI and study contact any

questions or concerns that arise during the review and negotiation of the terms and

conditions within the contract.

2. WISER (http://wiser.wakehealth.edu): For receipt of the proposed sponsor budget by

the Office of Clinical Research Study Administration team.

i. The draft budget received from the sponsor must be uploaded into this system.

ii. The OCR Study Administration group will communicate to the PI and study contact

any questions or concerns that arise during the build of the calendar and budget in

WISER.

3. eIRB (http://eirb.wakehealth.edu): For receipt of all regulatory items by the WFUHS

Institutional Review Board.

i. The regulatory documents must be uploaded into this system:

Protocol

Consent(s) and Assent(s) in the appropriate Wake Forest University Health

Sciences IRB templates

FDA IND/IDE Documentation

Investigator’s Brochure

ii. The IRB will communicate to the PI and study contact any questions or concerns that

arise during the regulatory review.

4. Review/Revision/Implementation:

a) Review Cycle: This policy shall be reviewed by the CTSI at least every 3 years from the

effective date.

5. Related Governing Policies:

Intake, Review, and Approval of Industry-Sponsored Human Subjects Research (03.005.OCR-P-01)




http://infoed.wakehealth.edu/

http://wiser.wakehealth.edu/

http://eirb.wakehealth.edu/

Budget Development and Negotiation for Industry-Sponsored Human Subjects Research (OCR-S-01-05)



Study Feasibility for Industry- Operating Procedure

\."\).Wake Forest· Sponsored Human Subjects SOP Number: OCR-S-O 1-03

Baptist Medical Center Research Original April 01, 2018

Effective Date: Current (Revised) Date:


Approval Signature~ Date of January 18, 2018 Signature:

Typed Name and Title: Christop~r O'Byrne Vice President & Associate Dean, Research Administration and Operations

1. General Purpose/Guideline Statement This Standard Operating Procedure (SOP) is intended to provide guidance on assessing the feasibility of industry-sponsored human subjects research to ensure that we are reviewing, approving and implementing human subjects research for which we have the appropriate subject population and resources to meet the objectives of the study.

a) Scope: All WFBMC employees, faculty and staff involved in the feasibility process of industrysponsored human subjects research.




b) Conflict of Interest (COl) in research: Situations in which financial or other personal considerations may compromise, or have the appearance of compromising a researcher's professional judgment in conducting or reporting research.

c) Clinical Research Organization (CRO): An organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. They may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.

d) Food and Drug Administration (FDA): An agency within the US Public Health Service that provides a number of health-related services. The FDA's services include monitoring the health of the nation's blood supply; ensuring that medicines, medical devices, and biologicals (such as insulin and vaccines) are safe and effective. The FDA must determine that a new drug produces the benefits it's supposed to produce, without causing side effects that would outweigh the benefits. The FDA has the power to force the manufacturer to make changes in the drug, change its safety labeling or marketing practices, or remove the medication from the market.

e) Guideline: A process or method for accomplishing a specific task or objective. All guidelines must comply with applicable WFBMC policies and procedures.

f) Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline, the term protocol refers to protocol and protocol amendments.

g) Institutional Review Board (IRB): The federally mandated committee charged with reviewing all

proposed human subjects’ research to protect the rights and welfare of the research

participants.

h) WFBMC: Wake Forest Baptist Medical Center and all affiliated organizations including Wake

Forest University Health Sciences (WFUHS), North Carolina Baptist Hospital (NCBH), and all on-site and off-site subsidiaries governed by WFBMC policies and procedures.

i) WISER: Wake Integrated Solution for Enterprise Research. The enterprise clinical research management system for WFBMC replacing CRMS, implemented in calendar year 2017.


There are five (5) major areas of feasibility that need to be considered prior to going through the

process of getting an industry-sponsored human subjects research study IRB-approved and

activated.

I. Evaluation of Study Implementation

a) It is important to evaluate whether or not the study aligns to the clinical research mission,

vision and goals of the Department, Service Line, and Institution. Questions to consider:

Do the clinical services and investigative treatments outlined in the protocol align with

or enhance our routine care of the subject population?

Does the study hold scientific merit and usefulness?

Does the study have an appropriate risk-to-benefit ratio for potential participants?

Will the IRB have any known ethical concerns about the trial?

Can any conflicts of interest be managed?

II. Evaluation of Existing Study Portfolio

b) It is important to evaluate whether or not the study aligns to the existing study portfolio in

the Department. A question to consider:

Are there any competing trials (studies currently open that are enrolling or providing

intervention to research participants of the same subject population and disease focus)?

III. Evaluation of Anticipated Enrollment

a) It is important to evaluate the feasibility to enroll subjects in a study prior to agreeing to

pursue opening the trial. Does WFBMC have the patient population to meet the enrollment

goals of the study? Are the eligibility criteria too restrictive? The CTSI Recruitment Unit can

assist with answering this feasibility question by providing the following resources:

The Translational Data Warehouse identifies patients in WakeOne that meet study

eligibility criteria. Data Requests can provide the number of eligible participants for

feasibility determination or questionnaires before study approval. It can also generate a

report of IRB-approved personal information such as address or primary physician that

can be used to recruit participants directly.

Recruitment Plan Consultations are small sessions led by the CTSI Recruitment

Coordinator to help study teams determine appropriate recruitment rates, review

eligibility requirements, determine enrollment goal feasibility, identify physicians

treating the target population for referrals, review advertising materials/methods, and

connect studies to inter-departmental services focused on recruitment budgets, special

populations, community engagement, and WakeOne recruiting.

IV. Evaluation of Resources

a) It is important to evaluate whether or not there are appropriate resources available to

conduct the study. Questions to consider:

Does the study require specialized equipment? Does WFBMC have the equipment or

will the sponsor provide this as part of the study?

Does the study require special, unique clinical services to be carried out? Does WFBMC

have the expertise to conduct these clinical services (are they part of our routine

standard practice)?

Do I have the appropriate staffing support to conduct the trial?

The CTSI offers a Study Coordinator Pool that provides Investigators with reliable,

experienced research staff to assist in the start-up, implementation, and closeout of

clinical research studies.

Do I have adequate clinical space to conduct the protocol activities?

The CTSI Clinical Research Unit (CRU) provides bionutrition, laboratory, and patient

care services for approved studies.

V. Evaluation of Funding

a) It is important to evaluate the financial feasibility of a study. This should be done in concert

with the Office of Clinical Research Study Administration group during the budgeting

process outlined in the SOP titled “Budget Development and Negotiation for Industry-

Sponsored Human Subjects Research”.





01)





01-05)


6. Revision Dates

Type: Tier 3 Standard Operatin~ Procedure

\X). Wake Forest- Study Start-Up for Industry- SOP Number: OCR-S-01-04 Original Baptist Med1cal Center Sponsored Human Subjects Effective Date:

April 01, 2018

Research Current (Revised) Date:

Contact: Orrice of Clinical

~ Research - CTSI

Approval Signature:~~ Date of February 15,2018 -- Si~nature:

Typed Name and Tirw. crmstophe'r"O'Byrne Vice President & Associate Dean, Research Administration and Operations

1. General Procedure/Guideline Statement:

This Standard Operating Procedure (SOP) is intended to describe the activities needed to open a

human subjects research study that will enroll participants at Wake Forest Baptist Medical Center

(WFBMC).

a} Scope: All WFBMC employees, faculty and staff involved with human subjects research are responsible for complying with this SOP.




b) CITI Program: The Collaborative Institutional Training Initiative (CITI Program) provides high quality, peeNeviewed, web-based educational courses in research, ethics, responsible conduct of research, other topics pertinent to the interests of member organizations and individual learners

c) Clinical Trial Agreement: The written agreement or contract between the study sponsor (or Contract Research Organization working on behalf of the sponsor) and WFBMC. This document contains information (exhibits or attachments) including the study budget

d) eiRB: The online protocol submission and review system for the Wake Forest University

Health Sciences Institutional Review Board (IRB). The eiRB provides a collaboration

workspace for the IRB and the Human Subjects Research community and is the location for

IRB review activities. eiRB is a commercial based software licensed from Click Commerce.

The software was introduced at Wake Forest in 2006, and has been highly customized to fit

the needs of the institution.

Study Start-Up for Human Subjects Research


e) Food and Drug Administration Amendments Act (FDAAA) Final Rule): This final rule details

the requirements for submitting registration and summary results information, including

adverse event information, for specified clinical trials of drug products (including biological

products) and device products for pediatric post-market surveillances of a device product to

ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National

Laboratory of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides

for the expanded registry and results data specified in Title VIII of the Food and Drug

Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they

may be eligible, enhance the design of clinical trials, and prevent the duplication of

unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase

the efficiency of drug and device development processes, improve clinical research practice,

and build public trust in clinical research. The requirements apply to the responsible party

(meaning the Sponsor or designed Principal Investigator) for certain clinical trials of drug

products (including biological products) and device products that are regulated by the Food

and Drug Administration ACT (FDA)and for pediatric post-market surveillances of a device

product that are ordered by FDA.

f) Good Clinical Practice: Good Clinical Practice (GCP) guidance is an international “ethical and

scientific quality standard” for designing, conducting, recording, and reporting clinical trials

in human subjects that was developed by the International Conference on Harmonization of

Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). The

GCP guidance developed by ICH is based on FDA regulations for the protection of human

subjects and defines the roles and responsibilities of Institutional Review Boards (IRBs),

investigators, monitors, and sponsors

g) InfoEd: The system used by 1) study teams for proposal development, routing to OSP and

system-to-system submission to external funding sources; 2) study teams to route contract

and other required routing documents to the Office of Sponsored Programs (OSP) 2) by

study teams to track and review timeline information on contract negotiations, contract

execution, and chartfield setup process for industry sponsored research-related

agreements, 3) by OSP contracts group as a contract negotiation management system, and

5) OSP for reporting and development of metrics related to industry supported contracts.

h) Institutional Review Board (IRB): The federally mandated committee charged with

reviewing all proposed human subjects research to protect the rights and welfare of the

research participants. It operates in accordance with the requirements for human subjects

research as set forth in the Code of Federal Regulations at 45 CFR 46 and 212 CFR 50, 56,

and other applicable federal and state regulations and laws, and, when applicable, the ICH-

GCP consolidated guidelines.


i) The Common Rule; 45 CFR Part 46: The Federal Policy for the Protection of Human Subjects

known as the “Common Rule. The common rule discusses the protections of human subjects

in 4 subparts; A-D.

Subpart A includes basic protection;

Subpart B includes protections for pregnant Women, Human Fetuses and Neonates

Involved in Research;

Subpart C includes protections pertaining to biomedical and behavioral research

Involving prisoners as Subject

Subpart D includes Protections for Children Involved as Subjects in Research

j) WFBMC: Wake Forest Baptist Medical Center and all affiliated organizations including Wake



k) WISER: Wake Integrated Solution for Enterprise Research is the enterprise clinical research

management system for WFBMC. It replaced CRMS in calendar year 2017.

3. Procedure/Guidelines:

Prior to Approval to Conduct Study

a) Obtain study material from sponsor; if investigator-initiated, obtain written material on the

drug/device (as applicable) and develop the written protocol

Note: If the sponsor requires you to sign a confidentiality disclosure agreement (CDA)

prior to sending you the study material, submit the CDA to the Office of Sponsored

Programs for approval before signing it. The department list for the Office of Sponsored

Programs is located at: https://ctsi.wakehealth.edu/contact-sponsored-programs

b) The Principal Investigator will delegate study staff to participate in the clinical study.

c) Study staff will sign the Study Site Signature/Responsibility Log (Exhibit A provided as a

template).

d) All study staff personnel that will be involved in study conduct will register on the CITI program by creating a user ID, password, and affiliating him or herself with Wake Forest School of Medicine. Then the staff member will complete training for Biomedical Investigators prior to being approved to work on the study by the IRB.

Study staff personnel involved in NIH-funded clinical trials are required to complete the CITI Good Clinical Practice (GCP) course, in addition to the Biomedical course.

Instructions for Enrolling in or renewing CITI Training is located at

https://ctsi.wakehealth.edu/citi-training-instructions

https://ctsi.wakehealth.edu/contact-sponsored-programs

https://ctsi.wakehealth.edu/citi-training-instructions


e) The Principal Investigator or designee will enter the draft agreement and preliminary budget

from the external Sponsor into InfoEd (http://infoed.wakehealth.edu/) and work with the

Office of Sponsored Program (OSP) Contract Officer representative until agreement

finalization.

f) The Investigator or the PI’s designee will use the IRB Informed Consent Template that is

appropriate for the study population’s age and native language when drafting consent

documents.

g) The adult informed consent; Assent forms (for children ages 7-10; 11-15; and 16-17) and parental permission templates are on the IRB Forms, Templates, and Tips page. The consent form will be drafted in the study population’s native language.

Short Form translations are available in the following languages; Arabic; English;

French; Lao; Russian; Spanish; Vietnamese.

h) The study team will work with the study sponsor on informed consent, assent, and parental permission forms prior to eIRB initial submission.

i) The Principal Investigator or designee will enter the clinical study in the WISER system: Wake Integrated Solution for Enterprise Research.

The Non-oncology protocol entry and oncology protocol entry workflows for WISER are located at https://ctsi.wakehealth.edu/WISER

j) The Principal Investigator or the Investigator’s designee will create an IRB application by

entering the Wiser # obtained from WISER into the eIRB Software located at eIRB Home.

k) The Principal Investigator or designee will upload the documents required for IRB

submission via the eIRB software.

Documents required for IRB submission are identified in section 8; Initial Submission

of the Wake Forest School of Medicine’s Human Research Protection Program and

Institutional Review Board Policies and Procedures

l) The Principal Investigator is required to make the initial submission of study materials for

IRB review to the Wake Forest IRB.

m) The Principal Investigator or the Investigator’s designee will develop and negotiate the study

budget with the external sponsor; as needed.

Budget management resources for Industry- Initiated studies are located at

https://ctsi.wakehealth.edu/Budget-Management

http://infoed.wakehealth.edu/

https://wiser.wakehealth.edu/forte-platform-web/login

https://ctsi.wakehealth.edu/WISER

https://eirb.wakehealth.edu/IRB/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5bOID%5bAC482809EC03C442A46F2C8EEC4D75D3%5d%5d



After IRB Approval, Contract Execution and Budget Finalization

a) The Principal Investigator or designee will file the IRB approved documents in the regulatory

binder according to the Document Retention Policy at

https://ctsi.wakehealth.edu/Portals/0/Human%20Research%20Unsecure/Document%20Sto

rage.pdf

b) The Principal Investigator or the Investigator’s designee will file written communication of

the site’s approval to participate in the clinical study, in the study binder. The Regulatory

Binder Checklist is found in Exhibit B.

c) The Principal Investigator or designee will register the Investigator-Initiated clinical trial on ClinicalTrials.gov (as required by the sponsor)

To request ClinicalTrials.gov support services, please complete the CTSI Service Request Form and select the “ClinicalTrials.gov Support/Consultation” option.

d) The Principal Investigator or designee will create source documents (if not provided by the sponsor) to record all study data.

e) All study staff personnel that will be involved in study conduct will train on the study protocol and document the training on the Site Training Log (Exhibit C).

4. Review/Revision/Implementation:

a) Review Cycle: This policy shall be reviewed by the CTSI at least every 3 years from the

effective date.

5. Related Governing Policies:

Intake, Review, and Approval of Industry-Sponsored Human Subjects Research (03.005.OCR-P-01)




Budget Development and Negotiation for Industry-Sponsored Human Subjects Research (OCR-S-01-05)


OSP Proposal Deadline and Review Policy

Standard Operating Procedure on the Registration of Clinical Trials in clinicaltrials.gov

Wake Forest School of Medicine Human Research Protection Program and Institutional Review Board Children Involved in Research Policy and Procedure

Wake Forest School of Medicine Human Research Protection Program and Institutional Review Board Informed Consent Policy and Procedure

Wake Forest School of Medicine Human Research Protection Program and Institutional Review Board Initial Submission Policy and Procedure.

https://ctsi.wakehealth.edu/Portals/0/Human%20Research%20Unsecure/Document%20Storage.pdf


https://redcap.wfubmc.edu/redcap/surveys/?s=M3EEWM34NJ

https://redcap.wfubmc.edu/redcap/surveys/?s=M3EEWM34NJ


6) References, National Professional Organizations, etc.:

Budget management resources for Industry: https://ctsi.wakehealth.edu/Budget-Management

CTSI Service Request Form:

https://redcap.wfubmc.edu/redcap/surveys/index.php?s=PYJWYTREAA

Document Retention Policy:

https://ctsi.wakehealth.edu/Portals/0/Human%20Research%20Unsecure/Document%20Sto

rage.pdf

ICH E6 (R2):

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R

2__Addendum_Step2.pdf

The Common Rule: https://www.hhs.gov/ohrp/regulations-and-

policy/regulations/common-rule/index.html

Food and Drug Administration Amendments Act; Section 801:

https://clinicaltrials.gov/ct2/manage-recs/fdaaa

Wake Forest IRB Policies and Procedures:

https://eirb.wakehealth.edu/IRB/Doc/0/GI6671HR6IHKD8DCMAFHUSPBDA/IRB%20policies

%205-6-16.pdf

Wake Integrated Solution for Enterprise Research Resources:


7) Attachments:

The Study Site Signature/Responsibility Log ………………………………………. Exhibit A

The Regulatory Binder Checklist ……………………………………… Exhibit B

The Site Training Log ………………………………………… Exhibit C

8) Revision Dates:



https://redcap.wfubmc.edu/redcap/surveys/index.php?s=PYJWYTREAA



http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf


https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

https://clinicaltrials.gov/ct2/manage-recs/fdaaa

https://eirb.wakehealth.edu/IRB/Doc/0/GI6671HR6IHKD8DCMAFHUSPBDA/IRB%20policies%205-6-16.pdf




Exhibit A

STUDY SITE SIGNATURE/ RESPONSIBILITY LOG

Principal Investigator:

IRB #:

Study Title:

PRINT

NAME TITLE SIGNATURE INITIALS

*DELEGATED

STUDY TASKS START DATE END DATE

*Delegated Study Tasks:

1. Obtain Informed Consent

2. Obtain Medical History

3. Perform Physical Exam

4. Obtain Vitals

5. Assess Eligibility Criteria

6. Draw labs

7. Maintain drug/device

accountability records

8. Dispense Study Drug/device

9. Evaluate AE (cause/severity)

10. Maintain Regulatory Docs

11. CRF completion

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

TO BE SIGNED AT STUDY CLOSURE: I confirm that this list accurately reflects the delegation of

responsibilities during the study

PI Signature ______Date: ______

Study Site Signature/Responsibility Log; Version 11.5.09


Exhibit B

Regulatory Binder Checklist Principal Investigator: IRB #: Study Title: Sponsor

Clinical Trial Regulatory Document Checklist

All Studies:

□ All IRB approved versions of the protocol

□ All IRB approved consent forms with watermark/date

□ IRB approval memos for all amendments

□ IRB approved advertisements/recruitment materials (brochures, flyers, web ads, etc.)

□ Written information provided to subjects (pain scales, diaries, questionnaires, etc.)

□ Initial IRB approval memo

□ Continuing Review approval memo(s)

□ Final Report to the IRB

□ CVs and licenses of PI and Co-PIs (update every 2 yrs/license annually)

□ Copy of Medical licenses

□ Site responsibility/staff signature log

□ Subject screening/enrollment log

□ Retained body fluids/tissue Sample Log

□ Protocol Deviation tracking log

□ DSMB Reports

□ Sponsor correspondence

□ Registration of clinical trial


Multicenter Studies in which WFUHS is the Prime Site:

□ All IRB approval memos from collaborating/subcontracting sites

□ All IRB stamped consent forms from collaborating/subcontracting sites

□ All IRB approved versions of the protocol from collaborating/subcontracting sites

□ Authorization agreement (if applicable)

□ Individual Investigator agreement (if applicable)

□ Data use agreement (if applicable)

Multicenter Studies in which WFUHS is not the Prime Site:

□ Subcontract agreement (defines scope of work, responsibilities, etc.)

NIH sponsored studies:

□ Copy of the NIH grant application

□ All progress reports submitted to NIH

□ NIH correspondence

□ FDA Regulated Studies:

□ 1571 (If applicable)

□ Signed 1572

□ FDA Form 3455 Financial Disclosure Forms for PI and sub-investigators on 1572

□ IB/Package Inserts/IDE information

□ All Investigational product shipping and receipt records

□ FDA correspondence


□ Drug/Device Accountability Logs

□ Lab certifications (CLIA)

□ Lab Director’s CV

□ Lab normals

□ Laboratory Shipment Log

□ Investigational New Drug (IND) safety reports received from Sponsor

Regulatory Binder Checklist; Version 1.27.11


Exhibit C

SITE TRAINING LOG


IRB #:

Study Title:

PRINT NAME OF

SITE STUDY STAFF TITLE SIGNATURE TYPE OF TRAINING

SIGNATURE OF

TRAINER DATE

PI Signature __Date: ____________

Site Training Log; Version 2.8.13


Budget Development and Operating Procedure

\\} Wake Forest- Negotiation for Industry- SOP Number: OCR-S-01-05

Baptist Medical Center Sponsored Human Subjects Original April 01, 2018

Effective Date: Research Current

_{_Revised) Date:


Approval Signatur~ Date of January 18, 2018

Signature:

Typed Name and ~hristo~ O'Byrne Vice President & Associate Dean, Research Administration and Operations

1. General Purpose/Guideline Statement This Standard Operating Procedure (SOP) is intended to provide guidance on the budgeting process for industry-sponsored human subjects research conducted at WFBMC. This SOP prescribes a systematic process to identify the costs of conducting human subjects research and establishes a consistent way to negotiate with sponsors in an attempt to obtain appropriate payment for research services rendered. This SOP will outline all steps from the collection of documentation to support the proposed budget through the negotiation and completion of the final budget.

a) Scope: All WFBMC employees, faculty and staff involved in the budgeting process of industrysponsored human subjects research.

b) Responsible Department/Parties: i. Procedure Owner: Clinical and Translational Science Institute (CTSI) ii. Procedure: Office of Clinical Research - CTSI iii. Supervision: Office of Clinical Research- CTSI iv. Implementation: Office of Clinical Research- CTSJ

2. Definitions: a) Billing Grid: An outline of all tests, procedures and interventions planned in a study by visit,

used as part of the Coverage Analysis process to determine the appropriate payer of the services rendered as part of the study. The final version of the billing grid (housed in WISER) is used after charge capture in WakeOne to determine where the clinical service will be charged.

b) Budget: A detailed statement outlining estimated project costs to support the sponsored project. A budget should include all the Direct Costs and Facilities and Administrative (F&A) (or overhead/indirect) costs required to carry out the project objectives.

c) Clinical Research Organizations (CRO): An organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. Also called "Contract Research Organizations".

d) Clinical Trial Agreement (CTA): The written agreement or contract between the study sponsor (or Contract Research Organization working on behalf of the sponsor) and WFBMC. This document contains information (exhibits or attachments) including the study budget.

e) Coverage Analysis: A systematic review of all procedures listed in the study protocol's schedule

of events to determine which ones are 'billable' and where these services should be billed.

Coverage Analysis is a required process for all human subjects research in which tests,

procedures, and interventions associated with the study are planned to be invoiced to third

party payers (the participating patient or their insurance).

f) Institutional Review Board (IRB): The federally mandated committee charged with reviewing all

proposed human subjects’ research to protect the rights and welfare of the research

participants.

g) WFBMC: Wake Forest Baptist Medical Center and all affiliated organizations including Wake

Forest University Health Sciences (WFUHS), North Carolina Baptist Hospital (NCBH), and all on-site and off-site subsidiaries governed by WFBMC policies and procedures.

h) WISER: Wake Integrated Solution for Enterprise Research. The enterprise clinical research management system for WFBMC replacing CRMS, implemented in calendar year 2017.


Information Gathering and Preliminary Budget Development

a) After the site feasibility and site approval process, industry sponsors will provide study teams

with a budget proposal. The budget proposal should be submitted by the study team to the

Office of Clinical Research (OCR) Study Administration team in WISER.

b) The Office of Clinical Research (OCR) Study Administration team will develop a WFBMC budget

in WISER to help support the study team’s negotiation of the budget with the sponsor. The OCR

Study Administration team will base their budget build in WISER on the following

documentation:

Proposed sponsor budget submitted in WISER

The Coverage Analysis they performed and Billing Grid they developed in WISER

Any ancillary service contract/memo(s) submitted in WISER

c) The WISER budget build will contain all appropriate technical (hospital) and professional codes

and their relevant cost based on the appropriate fee schedule. The WISER budget will also

contain all appropriate start-up costs, fixed costs, and indirect cost rates, based on sponsor type

and consultation with the study team.

d) The following documentation should be gathered by the PI/Designee to perform a thorough

review of the sponsor’s budget proposal:

Proposed sponsor budget

Draft clinical trial agreement from sponsor

Sample case report forms, if provided by sponsor

WFBMC Budget export from WISER developed by OCR Study Administration team

Protocol document

List of research personnel that will be involved in the conduct of the study and their

study role(s)

Ancillary services contract/memo(s)

e) The Principal Investigator and study team should review the sponsor budget to ensure that the

following costs are accounted for, as applicable:

All costs related to study start-up and close out;

Institutional costs related to all WFUHS IRB Review Fees, and MCA Fee (as applicable);

All fees related to any ancillary offices providing support to the study (e.g.,

Investigational Pharmacy, CTSI Clinical Research Unit, CTSI Study Coordinator Pool, CTSI

Network Research Team, Ophthalmology, Cardiology, etc.)

All Investigator time required for research activity (e.g., regulatory review and sign-off,

site initiation meeting(s), informed consent process, review of case report forms, other

document review, data analysis, monitoring visits, close-out meetings(s), etc. [Principal

Investigator and Co-Investigators];

All time spent by the research coordinator/nurse performing study-related activities

including: regulatory paperwork, site initiation meeting(s), screening potential subjects,

scheduling visits, obtaining informed consent, data collection and entry in case report

forms, monitoring visits, query resolution, on-call time, overtime, shift differential,

close-out meetings(s), etc.;

Screen failure events, IND Safety Reports, Serious Adverse Event Reporting, Con-Med

Reporting, External Audits, Informed consent translations, etc.

f) Estimate time associated with general participation on the study (including subject visits) for the

Principal Investigator, Co-Investigator, Study Coordinator, Research Nurse, and Data Coordinator

that is not accounted for in the procedural costs. These forecasted personnel costs should be

charged on an hourly basis, per subject, including total salary at the hourly rate inclusive of

fringe benefits.

If the study is canceled prior to enrollment, will the sponsor pay for pre-study activities,

e.g., IRB submission, meetings, chart reviews?

g) The Principal Investigator/Designee should ensure appropriate indirect costs are added in

sponsor budget.

Budget Negotiation

a) The Principal Investigator/Designee ensures all items above are addressed in the sponsor

template budget and returns the revised budget that accounts for all WFBMC costs to the

sponsor.

b) The payments offered by a for-profit industry sponsor must at least cover the costs of

conducting the study at WFBMC.

c) If WFBMC and the Sponsor are not able to reach agreement on a negotiated budget, the

Principal Investigator may utilize discretionary research funds or obtain Departmental funds

from their Chair to cover a study financial shortfall and the study can proceed.

Final Budget Management

a) The Principal Investigator/Designee submits the final negotiated budget from the sponsor to

WISER so that the OCR Study Administration team can update the WISER budget to reflect the

final approved costs.

b) The Principal Investigator/Designee provides approval of the study in WISER once OCR Study

Administration updates to the WISER budget are complete.

WFBMC Entity Responsibility

Principal Investigator/ Designee

Performs WISER submission to provide sponsor template budget to OCR Study Administration team.

Provides relevant CPT codes related to clinical services to be performed in study.

Utilizes WISER internal budget to negotiate with Sponsor.

Provides final approval of WISER budget.

Office of Clinical Research (OCR) Builds budget in WISER.





01)






6. Revision Dates


Site Initiation Visits for Industry- Operating Procedure

\.\} Wake Forest~ Sponsored Human Subjects SOP Number: OCR-S-01-06

Baptist Medrcal Certer Research Original April 01, 2018

Effective Date: Current (Revised) Date:

Contact: Ortice of Clinical Research - CTSI

Approval Signatu~~ Date of January 18, 2018 ----- Signature:

Typed Name an~ri~her O'Byrne Vice President & Associate Dean, Research Administration and Operations

1) General Procedure/Guideline Statement:

This Standard Operating Procedure describes the processes followed by Wake Forest Baptist

Medical Center (WFMC) study site personnel before a site initiation visit, during the visit, and after

the visit is completed. The SOP covers the Study Site visit that prepares the Investigator and Study

Staff Personnel to :

o Implement the protocol accord ing to Good Clin ical Practice (GCP) requirements

o Obtain clarification of protocol procedures

o Receive direction on Case Report Form (CRF) completion requirements

a) Scope WFBMC employees, faculty and staff involved in human subjects research studies

subject to Investigational New Drug (IN D) regulations for drugs and biologics, as well as

study personnel working on human subjects research studies subject to Investigational

Device Exemption (IDE) regulations.

b) Responsible Department/Party/Parties:

i. Procedure Owner: Clinical and Translational Science Institute (CTSI)

ii. Procedure: Office of Clinical Research- CTSI

iii . Supervision: Office of Clinical Research - CTSI

iv. Implementation: Office of Clinical Research- CTSI

2) Definitions:

a) Case Report Form: Document (printed or electronic) designed to record all the protocol

required information to be reported to the sponsor on each trial subject

b) CLIA Waiver of Certificate: A waiver that allows the Principal Investigator or designee to

perform point of care testing such as urine pregnancy testing and urine drug testing in an

individual department/clinic

c) Clinical Research Unit (CRU): The centralized space that provides bio-nutrition, laboratory,

and patient care services for IRB approved studies. All types of studies including industry,

federal, and investigator initiated sponsored research are conducted in the CRU.

Site Initiat ion Visit for Human Subjects Research

'

Site Initiation Visit for Human Subjects Research

d) Device Accountability Log: A document that tracks and documents when and how the

investigational device has been used throughout the clinical trial

e) Drug Accountability Log: A document that tracks and documents when and how the

investigational product has been used throughout the clinical trial

f) Good Clinical Practice: Good Clinical Practice (GCP) guidance is an international “ethical and

scientific quality standard” for designing, conducting, recording, and reporting clinical trials

in human subjects that was developed by the International Conference on Harmonization of

Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). The

GCP guidance developed by ICH is based on FDA regulations for the protection of human

subjects and defines the roles and responsibilities of Institutional Review Boards (IRBs),

investigators, monitors, and sponsors.

g) Institutional Review Board (IRB): The federally mandated committee charged with

reviewing all proposed human subjects’ research to protect the rights and welfare of the

research participants. It operates in accordance with the requirements for human subjects

research as set forth in the Code of Federal Regulations at 45 CFR 46 and 212 CFR 50, 56,

312, and 812 and other applicable federal and state regulations and laws, and the ICH-GCP

consolidated guidelines.

h) Investigator: The principal investigator is the individual responsible for the conduct of

research, and, as such, must personally conduct or supervise the research. The PI is

responsible for ensuring that the research study is accurately and completely submitted for

IRB review; that IRB approval is obtained prior to initiation of research or before making any

changes or additions to the research; that the IRB is informed of new information (e.g. from

the study sponsor) or changes to information previously presented to the IRB, and work

with the IRB to determine if and how new information should be communicated to

participants.; that progress reports are submitted to the IRB as required; that all non-

compliance is reported to the IRB; and that all unanticipated problems or serious adverse

events involving risk to human subjects are reported to the IRB.

The principal investigator is responsible for the delegation of responsibilities of study

conduct to other study team members based on experience and qualifications. Trainees

such as medical students, residents, and fellows are not permitted to have the role of

principal investigator, and must have a sponsor/mentor to support, oversee, and submit

their research application

i) Monitoring Log: A log that contains a comprehensive list of all monitoring visits. The Sponsor’s representative; often a study monitor, will record visits as they occur on the monitoring log by documenting the date of the monitoring visit, and description of the monitoring activity before signing the entry. Afterward, the PI or the study staff will sign the monitoring log entry to confirm the monitoring visit.


j) Point of Care Testing: Medical diagnostic testing performed at the place of patient care

k) Protocol: A detailed plan for a clinical trial that describes the objective(s), design, methodology, statistical considerations, and organization of the clinical trial.

l) Regulatory Binder (or Files): – Place where all study-specific information and regulatory documentation, including IRB approved protocols, amendments, informed consent, case report forms, FDA 1571 and 1572 (if applicable) and recruitment materials, is maintained. The regulatory binder provides a thorough history of the research study from protocol development to study completion.

m) Sponsor: An individual, company, institution or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

n) Contract Research Organization (CRO) – A company, institution or organization contracted by the sponsor to manage the trial.

o) Study Site Personnel- Refers to study personnel that are delegated by the Investigator to perform clinical trial activities.

p) WFBMC: Wake Forest Baptist Medical Center and all affiliated organizations including Wake



3) Procedure/Guidelines:

Before the Site Initiation Visit

a) The Principal Investigator or designees should consult with ancillary staff, such as

pharmacists, laboratory technicians, radiology, the Clinical Research Unit about study

procedures that need ancillary services before study initiation.

b) Study site personnel will arrange with the monitor the scheduled date, time, and location of

the study initiation visit.

c) Study site personnel should ensure that sub Investigator(s), pharmacist(s), research coordinators and any other relevant staff involved with the study have been advised of the Site Initiation Visit and request that they make every effort to attend

d) The Investigator or Study site personnel should file the following in the regulatory binder, as

directed by the study sponsor:

The IRB-Approved Protocol

The IRB-Approved Consent Form(s); including assent form(s) and the parental

permission form; if applicable

Advertisements to be used for subject recruitment; if applicable


Instructions for Use and any other information that will be provided to participants

Investigator’s Brochure

Wake Forest IRB Membership Roster

Central IRB Membership Roster; if the site is using the study’s Central IRB

CV of the Principal Investigator

CV of the Sub-Investigators

Shipping records for Investigation product/investigational device and trial related

materials

Current laboratory reference ranges for protocol-required tests

Laboratory certificate of accreditation

A CLIA waiver of certificate for Point of Care Testing performed in the department; if

applicable

Investigator Agreement (for device studies)

Investigator’s medical license

The following documents must be originals and/or contain wet ink signatures:

Signed Form FDA 1572 for Industry-Sponsored drug studies

The Site Training Log

IATA training certificates for staff responsible for handling and shipping biological

specimens

Study specific training certificated (i.e. sponsor trainings, EDC, module completions)

The Study Site Signature/Responsibility Log

Protocol and Investigator Brochure Acknowledgement Forms

e) The Principal Investigator/Designee or Investigational Pharmacist (if IDS is involved in drug

accountability) will document investigational products. Investigational device accountability

should be performed by the Principal Investigator/Designee.

Investigational drug or device that is received prior to the site initiation visit will be

stored in a secure area, according to the Investigator’s Brochure, Pharmacy Manual, or

protocol.

f) Study site personnel should ensure that the study staff member or pharmacy staff

responsible for maintaining or dispensing the investigational product has completed the sponsor

required trainings and has access to the study’s drug supply/shipment management and

randomization systems.

g) Study site personnel should store study supplies such as lab kits, Case Report forms,

Regulatory Binders etc. in a secure area

h) Study site personnel should ensure that the subject payment procedure is in place, if

applicable

https://eirb.wakehealth.edu/IRB/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B8B5C953C7DCBAA4A9C5790944AFC1F61%5D%5D


During the Site Initiation Visit

a) Study staff personnel should have the regulatory binder available for the Sponsor

representative’s review during the Site Initiation Visit

b) The Investigator and other Study staff personnel should receive instruction on implementing

the protocol, the performance of protocol procedures, Case Report Form (CRF) completion,

the investigational product or investigational device, reporting requirements for adverse

events, etc. from the study sponsor.

c) Study staff personnel may provide the Sponsor’s representative a tour of the following

areas, as applicable:

Pharmacy or drug/device storage facilities

Space for conducting study visits

Lab facilities; if required

The Clinical Research Unit (CRU); if the clinical trial will be conducted in the CRU

After the Site Initiation Visit

a) Study staff personnel should confirm that the Sponsor’s representative conducted the site

initiation meeting by witnessing the representative’s signature on the Monitoring Log.

b) Study staff personnel may receive the Site Initiation follow-up letter and are expected to

carry out the recommendations listed in the letter.

c) Study staff personnel will file the Site Initiation Follow-up letter and the Site Initiation

Monitoring Report (if received) in the regulatory binder.

4) Review/Revision/Implementation:

This policy shall be reviewed by the CTSI at least every 3 years from the effective date.

5) Related Governing Policies:

Intake, Review, and Approval of Industry-Sponsored Human Subjects Research

(03.005.OCR-P-01)





Budget Development and Negotiation for Industry-Sponsored Human Subjects Research

(OCR-S-01-05)


6) References, National Professional Organizations, etc.:

ICH E6 (R2): Good Clinical Practice

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E

6_R2__Addendum_Step2.pdf

IDE Responsibilities:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYou

rDevice/InvestigationalDeviceExemptionIDE/ucm046702.htm

Investigational New Drug Application; General Responsibility of Investigators (21 CRF

312.60):

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.60

Investigational Device Exemption; Subpart E- Responsibilities of Investigators (21 CRF

812);

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812

&showFR=1&subpartNode=21:8.0.1.1.9.5

Wake Forest IRB Policies and Procedures:

https://eirb.wakehealth.edu/IRB/Doc/0/GI6671HR6IHKD8DCMAFHUSPBDA/IRB%20poli

cies%205-6-16.pdf

Attachments

Regulatory Binder Checklist ..……………………………………… Exhibit A

Device Accountability Log .………………………………………. Exhibit B

Drug Accountability Log ……………………………………….. Exhibit C

Monitoring Log ……………………………………….. Exhibit D

7) Revision Dates:



https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046702.htm

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046702.htm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.60

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812&showFR=1&subpartNode=21:8.0.1.1.9.5

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812&showFR=1&subpartNode=21:8.0.1.1.9.5




Exhibit A

Regulatory Binder Checklist Principal Investigator: IRB #: Study Title: Sponsor:

Clinical Trial Regulatory Document Checklist

All Studies:

□ All IRB approved versions of the protocol

□ All IRB approved consent forms with watermark/date

□ IRB approval memos for all amendments

□ IRB approved advertisements/recruitment materials (brochures, flyers, web ads, etc.)

□ Written information provided to subjects (pain scales, diaries, questionnaires, etc.)

□ Initial IRB approval memo

□ Continuing Review approval memo(s)

□ Final Report to the IRB

□ CVs and licenses of PI and Co-PIs (update every 2 yrs/license annually)

□ Copy of Medical licenses

□ Site responsibility/staff signature log

□ Subject screening/enrollment log

□ Retained body fluids/tissue Sample Log

□ Protocol Deviation tracking log

□ DSMB Reports

□ Sponsor correspondence

□ Registration of clinical trial


Multicenter Studies in which WFUHS is the Prime Site:

□ All IRB approval memos from collaborating/subcontracting sites

□ All IRB stamped consent forms from collaborating/subcontracting sites

□ All IRB approved versions of the protocol from collaborating/subcontracting sites

□ Authorization agreement (if applicable)

□ Individual Investigator agreement (if applicable)

□ Data use agreement (if applicable)

Multicenter Studies in which WFUHS is not the Prime Site:

□ Subcontract agreement (defines scope of work, responsibilities, etc.)

NIH sponsored studies:

□ Copy of the NIH grant application

□ All progress reports submitted to NIH

□ NIH correspondence

□ FDA Regulated Studies:

□ 1571 (If applicable)

□ Signed 1572

□ FDA Form 3455 Financial Disclosure Forms for PI and sub-investigators on 1572

□ IB/Package Inserts/IDE information

□ All Investigational product shipping and receipt records

□ FDA correspondence


□ Drug/Device Accountability Logs

□ Lab certifications (CLIA)

□ Lab Director’s CV

□ Lab normals

□ Laboratory Shipment Log

□ Investigational New Drug (IND) safety reports received from Sponsor

Regulatory Binder Checklist; Version 1.27.11


Exhibit B

DEVICE ACCOUNTABILITY LOG

IRB Protocol No.

Study Title:

Principal Investigator: Sponsor:

Type of Device:

Receipt and Identification of Each Individual Device

Device Disposition

Date Received

Identification as Noted on Label

Subject ID Date Destroyed

Date Returned

Reason Returned

Received by (initials)

Model # Serial # Lot # Date Used or Dispensed

By whom Returned by (initials)

1

2

3

4

5

NOTE: Retain a copy of the packing slips for all shipments received and sent

Device Accountability Log; Version 1.27.11


Exhibit C

DRUG ACCOUNTABILITY LOG

IRB Protocol No.

Study Title:

Principal Investigator: Sponsor:

Drug Name:

Receipt and Identification of Each Individual Device

Device Disposition

Date Received

Identification as Noted on Label Subject ID Quantity Dispensed

Quantity Returned

Received by

(initials)

Received by (initials)

Lot/kit # Bottle # Dosage Date Returned

By whom Date

Returned 1

2

3

4

5

NOTE: Retain a copy of the packing slips for all shipments received and sent

Drug Accountability Log; Version 1.27.11


Exhibit D

MONITORING LOG


IRB#:

Study Title:

Sponsor:

Date of Monitoring

Activity

Description of Monitoring Activity

(i.e.- pre-site, initiation, routine,

external audit)

Monitor Name

and Signature

PI/Study Staff

Signature

Monitoring Log; Version 6/5/08