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Study Feasibility and Start-up
Tiffany Morrison MS CCRP
Director Clinical Trials
Rothman Institute
Learning Objectives
bull Outline a few examples of things that are necessary to
consider when yoursquore assessing study feasibility at your site
bull Explain why it is necessary to sign a CDA prior to initiating
contact with the Sponsor of a study
Startup Activities
Image courtesy of CITI
Program Clinical Research
Coordinator course
Interest LettersFeasibility Questionnaires What are they
What do you do with them
Interest Letters Feasibility Questionnaires
Inquiry from a Sponsor or CRO (Contract Research
Organization) to ascertain if there is interest and the
ability to participate as a site in a clinical trial
bull Come in many forms with varying amounts of information
bull Usually include a Site Selection and Feasibility Questionnaire
bull Completed by the Investigator andor the CRC
bull Good practice to notify the Business Manager if interested
bull httpwwwdfhccharvardeduresearchclinical-research-supportcrs-search-
resultstx_hcc_search5Bquery5D=feasibility+
Interest Letters Feasibility Questionnaires
Sponsor Interested Investigator Interested
Sponsor contacts the Investigator and coordinator listed
in Feasibility Questionnaire
Sponsor sends CDA (Confidentiality Disclosure Agreement)
and sets up a Site Selection Visit
Confidentiality Disclosure Agreement CDA
Written agreement ensuring that investigators andor
staff do not disclose the contents of the protocol or
proprietary information regarding the study
bull A legal document
bull Needs to be reviewed by ORA JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Learning Objectives
bull Outline a few examples of things that are necessary to
consider when yoursquore assessing study feasibility at your site
bull Explain why it is necessary to sign a CDA prior to initiating
contact with the Sponsor of a study
Startup Activities
Image courtesy of CITI
Program Clinical Research
Coordinator course
Interest LettersFeasibility Questionnaires What are they
What do you do with them
Interest Letters Feasibility Questionnaires
Inquiry from a Sponsor or CRO (Contract Research
Organization) to ascertain if there is interest and the
ability to participate as a site in a clinical trial
bull Come in many forms with varying amounts of information
bull Usually include a Site Selection and Feasibility Questionnaire
bull Completed by the Investigator andor the CRC
bull Good practice to notify the Business Manager if interested
bull httpwwwdfhccharvardeduresearchclinical-research-supportcrs-search-
resultstx_hcc_search5Bquery5D=feasibility+
Interest Letters Feasibility Questionnaires
Sponsor Interested Investigator Interested
Sponsor contacts the Investigator and coordinator listed
in Feasibility Questionnaire
Sponsor sends CDA (Confidentiality Disclosure Agreement)
and sets up a Site Selection Visit
Confidentiality Disclosure Agreement CDA
Written agreement ensuring that investigators andor
staff do not disclose the contents of the protocol or
proprietary information regarding the study
bull A legal document
bull Needs to be reviewed by ORA JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Startup Activities
Image courtesy of CITI
Program Clinical Research
Coordinator course
Interest LettersFeasibility Questionnaires What are they
What do you do with them
Interest Letters Feasibility Questionnaires
Inquiry from a Sponsor or CRO (Contract Research
Organization) to ascertain if there is interest and the
ability to participate as a site in a clinical trial
bull Come in many forms with varying amounts of information
bull Usually include a Site Selection and Feasibility Questionnaire
bull Completed by the Investigator andor the CRC
bull Good practice to notify the Business Manager if interested
bull httpwwwdfhccharvardeduresearchclinical-research-supportcrs-search-
resultstx_hcc_search5Bquery5D=feasibility+
Interest Letters Feasibility Questionnaires
Sponsor Interested Investigator Interested
Sponsor contacts the Investigator and coordinator listed
in Feasibility Questionnaire
Sponsor sends CDA (Confidentiality Disclosure Agreement)
and sets up a Site Selection Visit
Confidentiality Disclosure Agreement CDA
Written agreement ensuring that investigators andor
staff do not disclose the contents of the protocol or
proprietary information regarding the study
bull A legal document
bull Needs to be reviewed by ORA JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Interest LettersFeasibility Questionnaires What are they
What do you do with them
Interest Letters Feasibility Questionnaires
Inquiry from a Sponsor or CRO (Contract Research
Organization) to ascertain if there is interest and the
ability to participate as a site in a clinical trial
bull Come in many forms with varying amounts of information
bull Usually include a Site Selection and Feasibility Questionnaire
bull Completed by the Investigator andor the CRC
bull Good practice to notify the Business Manager if interested
bull httpwwwdfhccharvardeduresearchclinical-research-supportcrs-search-
resultstx_hcc_search5Bquery5D=feasibility+
Interest Letters Feasibility Questionnaires
Sponsor Interested Investigator Interested
Sponsor contacts the Investigator and coordinator listed
in Feasibility Questionnaire
Sponsor sends CDA (Confidentiality Disclosure Agreement)
and sets up a Site Selection Visit
Confidentiality Disclosure Agreement CDA
Written agreement ensuring that investigators andor
staff do not disclose the contents of the protocol or
proprietary information regarding the study
bull A legal document
bull Needs to be reviewed by ORA JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Interest Letters Feasibility Questionnaires
Inquiry from a Sponsor or CRO (Contract Research
Organization) to ascertain if there is interest and the
ability to participate as a site in a clinical trial
bull Come in many forms with varying amounts of information
bull Usually include a Site Selection and Feasibility Questionnaire
bull Completed by the Investigator andor the CRC
bull Good practice to notify the Business Manager if interested
bull httpwwwdfhccharvardeduresearchclinical-research-supportcrs-search-
resultstx_hcc_search5Bquery5D=feasibility+
Interest Letters Feasibility Questionnaires
Sponsor Interested Investigator Interested
Sponsor contacts the Investigator and coordinator listed
in Feasibility Questionnaire
Sponsor sends CDA (Confidentiality Disclosure Agreement)
and sets up a Site Selection Visit
Confidentiality Disclosure Agreement CDA
Written agreement ensuring that investigators andor
staff do not disclose the contents of the protocol or
proprietary information regarding the study
bull A legal document
bull Needs to be reviewed by ORA JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Interest Letters Feasibility Questionnaires
Sponsor Interested Investigator Interested
Sponsor contacts the Investigator and coordinator listed
in Feasibility Questionnaire
Sponsor sends CDA (Confidentiality Disclosure Agreement)
and sets up a Site Selection Visit
Confidentiality Disclosure Agreement CDA
Written agreement ensuring that investigators andor
staff do not disclose the contents of the protocol or
proprietary information regarding the study
bull A legal document
bull Needs to be reviewed by ORA JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Confidentiality Disclosure Agreement CDA
Written agreement ensuring that investigators andor
staff do not disclose the contents of the protocol or
proprietary information regarding the study
bull A legal document
bull Needs to be reviewed by ORA JCRI Business
Operations prior to returning to Sponsor (or sending
out in the case of IIT)
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
How to Read a Protocol (Quickly) Title
Table of Contents
Protocol Synopsis
bull Number of Centers (US or worldwide)
bull Number of subjects
bull Target population
bull Objectives
bull Treatment planduration
bull InclusionExclusion
Tables
bull Study Schema
bull Study Events Table (read the superscript)
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Study Events Table Example
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Study Schema Example
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Assessing Protocol Feasibility
bull The ability to enroll patients is paramount to success
bull Adequate patient population
bull Competing protocols
bull Resources required to execute protocol activities available
bull What information will be collected and how
bull Additional training space or equipment required
bull Adequate availability of time PI and CRC
bull Opportunity for scientific publication or authorship
bull Possibility of strengthened collaborations with sponsor for future
studies
bull Cost to conduct study versus proposed funding (if any)
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Assessing Protocol Feasibility
bull Is it necessary to collaborate with other departments for this
protocol
bull Microbiology send protocol and make sure theyrsquore able to
perform all necessary testing
bull Investigational Drug Service very important to bring IDS into
this process as early as possible
bull IDS will determine if theyrsquore able to prepare drug according to
protocol and will help work through logistics
bull Radiology MRI protocols scanning protocols are often specific
Need to make sure wersquore capable of completing the radiological
section of the protocol
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Site Selection Visit
bull Aka Pre-Selection Visit (PSV)
bull Not to be confused with a Site Initiation Visit (SIV)
bull Sponsor will visit site to confirm facilities and staff are
adequate to perform protocol
bull Will review the protocol discuss any potential
obstacles and confirm commitment
bull Sponsor may collect some regulatory documents
(Investigators CV and license lab certificates etc)
bull Make sure you schedule time with additional
Departments as necessary
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
Next Steps Clinical Research Pre-Award Process
14
App
licat
ion
IRB
Contract
Budget
bull IRB Submission and JCRI Business Operations Submission are Parallel Processes
Approval
Letter
