Investigator Site File (ISF) useful quality assurance (QA) templates

all studies

Version 4, 05 Nov 2010

Use this as a template which can be amended according to your specific study requirements (add/delete table columns/rows, change column headers etc)

following your study specific changes we recommend to save each template separately, as any version changes (see footer of this document) are unlikely to affect all logs at the same time (easiest might to t o save under the new file name, e.g. Partic_Screen_Recruit_log_V1 and delete the not wanted templates; then again save as Staff_Deleg_log_V1 etc)

Please remember to version control all templates – in case you amend/improve them this will make a new version

we recommend pre-printing a few File Notes (with Study details at the top already pre-inserted), so that these are readily available

Further guidance on SCRI Information Sheets 17 via the R&D website Index templates, study type specific (CTIMP, Medical Device, non-CTIMP/non-device) see

R&D website http://www.suht.nhs.uk/Research/Researchers/InvestigatorSiteFiles/InvestigatorSiteFiles.aspx

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site       Participant/Subject Screening and Recruitment Log

Participant Code and

Initials

Participant hospital/

NHS number

Male/

Fem.

Date approache

d dd/mmm/yyyy

Date consented/Screeneddd/mmm/yyyy

OutcomeY-N

Brief reason forscreening failure or

does not wish to participate

Random.to group

End dateWithdrawal

datedd/mmm/yyyy

Completed study

Y/N

RecruitedScreening failureRecruitedScreening failureRecruitedScreening failureRecruitedScreening failureRecruitedScreening failureRecruitedScreening failureRecruitedScreening failureRecruitedScreening failure

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site      

Study Specific Document Log

Participant Identification

Number

Particip. Initials

Date consent given

(dd/mm/yyyy)

Participant Information Sheet Signed Informed Consent Form GP letter Staff initials

Version no.

*Copy given to

participant

*Copy into medical records

*Original to site file

*Copy to participant

*Copy to medical records

*Sent to GP

*Copy to medical records

* Insert staff initials and date if different from consent date, amend columns to suit your logistics

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12-WEEK EXEMPTION STATEMENT(Please refer to Information Sheet IS4b)

Can be requested from R&D either participant specific or for all participants who consent Must be signed by PI or delegated medic

latest version: http://www.suht.nhs.uk/research/researchers/settinguparesearchstudy/informationsheets.aspx

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site      

Site Staff Signature & Delegation of Site Tasks logSurname, first name Role in Study

(e.g. Res Nurse, Admin, Doctor, Sub-

investigator)

SUHT LoA

HRC*

Start date

End date

Tasks delegated/ permitted**

Sample initials

Sample Signature and sample

1, 2,3,4,5,6,7,8,9,0

Signature of PI as approved

Principal Investigator n.a.

*SUHT employed, Honorary Clinical Consultant, Letter of Access or Honorary Research Contract for SUHT in place**Please list study tasks where applicable for the staff qualification, tasks can be grouped, as done below for 31. Screening, first approach 6. Study drug administration (vaccination) 11. Data audit, SDV (Source Data

Verification)2. Consenting 7. specific interventions

(questionnaires/interviews, laser fluximetry, bronchoscopy)

12. self-audit/monitoring

3. Medical examination (inclusion/exclusion, AE/SAE assessment, prescribing)

8. lab processing 13. Sorting documents into ISF

4. Prescribing drugs 9. study specific training of staff 14. archiving

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5. Venesection 10. Data entry into CRF and into medical notes 15.

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Safety Reporting (Pharmacovigilance/Medical Device Adverse Effects)

1. Immediate Reports SAE, SUSAR, SADE Guidance and forms to complete:

http://www.suht.nhs.uk/Research/Researchers/ResearchGovernance/SafetyReportingRequirements.aspx

2. Periodic Reports 6-monthly safety report (only for commercially sponsored CTIMPS that are running with

worldwide sites) Annual Safety report: for CTIMPS in addition to Annual Progress Report, guidance and forms to

complete see http://www.suht.nhs.uk/Research/Researchers/ResearchGovernance/SafetyReportingRequirements.aspx

3. Safety – Definitions and Reporting

Adverse event (AE) - any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product.

Serious adverse event (SAE) – an adverse event that: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or consists of a congenital anomaly or birth defect.

Adverse Reaction - any untoward and unintended response in a subject to an investigational medicinal product/medical device/intervention which is related to any dose administered to that subject.

Serious Adverse Reaction (SAR) – and adverse reaction that: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or consists of a congenital anomaly or birth defect.

Suspected Serious Adverse Reaction (SSAR) - any serious adverse reaction that is suspected (possibly or probably) to be related to the investigational medicinal product/medical device/intervention.

Suspected Unexpected Serious Adverse Reaction (SUSAR) or Serious Adverse Device Effect (SADE) - an SSAR/adverse effect which is also “unexpected”, meaning that its nature and severity are not consistent with the information about the medicinal product/medical device in question set out:

For full guidance on recording and reporting requirements for Adverse Events and Adverse Reactions and SUHT Research Related Adverse Event Reporting Policy please refer to:http://www.suht.nhs.uk/Research/Researchers/ResearchGovernance/SafetyReportingRequirements.aspx

To ensure you are using the latest versions of the forms and following the most up-to-date process please access the policy, forms and information sheets from the web site at the

time you require them.

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site      

Adverse Event log (for CTIMPs/Medical Device Investigations use more detailed AE log from Research related Adverse Events Policy, via weblink above

Sequelae

Date of AE(dd/mmm/yyyy)

ParticipantIdentificat. Number

Partici. Initials

Description(separate rows, e.g. vomiting and

diarrhoea)

Was this a SAE? Possibly related to study

intervention

Staff initials for medical

assessment

Date SAE reported to

Sponsor and R&D

Y N Y N

Y N Y N

Y N Y N

Y N Y N

Y N Y N

Y N Y N

Y N Y N

Y N Y N

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site      

Amendment Log / Version control

Ensure whole Research Team is informed of new versions, and previous ones are clearly marked as superseded in ISF (diagonal cross through front page with date, initials).

Document Version date

Substantial amendment approval Date amendment

communicated to team/s

Brief description of amendment Staff initialsMHRA

Date REC/GTAC

Date R&D Date

Protocol Version no.

Version no.

Version no.

Version no.

Version no.

Version no.

Version no.

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Document Version date

Substantial amendment approval Date amendment

communicated Brief description of amendment Staff

initialsInformed Consent

Form

Version no.

Version no.

Version no.

Version no.

Version no.

Participant Information

Sheet

Version no.

Version no.

Version no.

Version no.

Version no.

GP Letter Version no.

Version no.

Version no.

Other Version no.

Version no.

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site      

Record of retained body fluids / tissue samples

ParticipantIdentificat. Number

Partici. Initials

Participant consent

provided for future use?

Date sample collected

(dd/mmm/yyyy)

Sample Type Storage location* Storage periodFrom To

(date sample destroyed or transferred)

            Y N                              

            Y N                              

            Y N                              

            Y N                              

            Y N                              

            Y N                              

            Y N                              

            Y N                              

            Y N                              

            Y N                              

*Please specify, Building, department, location and type of storage facility (e.g. lab freezer, paraffin block)Insert extra column if consent was also received for future undefined research.

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site      

Annual/Periodical Requirements log What Year 1

Date doneStaff

initialsYear 2

Date done Staff

initialsYear 3

Date doneStaff

initialsYear 4

Date doneStaff

initials

Annual Progress Report Due every year on: (Insert initial REC approval day/month – send to REC, Sponsor and copy to R&D)Annual audit staff are all on Delegation log, CVs/GCP up-to-date/in file?Add further annual/quarterly audits as you wish

CTIMPs and Medical Device Investigations

Annual Safety ReportDue every year on: (Insert initial MHRA authorisation day/month, send to MHRA, copy to Sponsor, REC and R&D)Annual Review/Update of Investigator’s Brochure<InsertDue every year on:(File in ISF, alert research team of changes)Annual Check SPC<InsertDue every year on:(Check whether Summary of Product Characteristics for licensed medicine has changed; if yes, copy into ISF, alert research team or have File Note with www location of latest SpC)Repeat IB or SPC rows if more than one IMP is used

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Pharmacy Standard Operating Procedure (SOP) for conducting clinical trials involving medicines.

Any investigator who undertakes research within Southampton University Hospital Trust (SUHT) whether University or NHS based must adhere to the following rules.

All investigators conducting clinical trials that involve any type of medicines or drugs must inform pharmacy well in advance of the trial beginning. This applies to:

- Commercially sponsored trials- MRC trials- Investigator led trials- Healthy volunteer studies

‘All medicines for clinical trials should be ordered, stored and dispensed by the hospital pharmacy’ Controls Assurance Standard NHS Executive Feb 2000

A Clinical Trial Authorisation (CTA) must be obtained from the Medicines and Healthcare Products Regulatory Agency (MHRA) for all trials involving the use of an Investigational Medicinal Product (IMP). It is the responsibility of the study sponsor or CI/PI as applicable to ensure a CTA is applied for; the CTA replaces the previous Clinical Trial Exemption (CTX) and Doctor’s and Dentist’s Exemption (DDX) schemes. Pharmacy will need to have copy for their file.

Pharmacy will need names of research nurses and the signature of prescribing clinician(s).

Confirmation of which directorate and cost centres should be charged.

Pharmacy must be informed if and when the trial is discontinued or closed.

Pharmacy will levy charges appropriate to the level of service and involvement required. These charges must be taken into consideration when estimating costs.

Pharmacy contact: Joanna Cantle - Bleep 1237 Pharmacy lead for R&D and Clinical Trials

References:Controls Assurance Standard Medicines Management NHS Executive Feb 2000GCP for trials on Medical Products in the European CommunityGuidelines for the Safe and Secure Handling of medicines (Duthie Report 1988)Medicines Act 1968

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Study short title       Ethics No.      R&D No. RHM       Principal Investigator      Sponsor       Site      

Drug Accountability Log

DRUG RECEIPTS DATE BATCH NUMBER EXPIRY QUANTITY RECEIVED SIGNATURE

DISPENSING LOG DATE PARTIC.

INITIALSPARTIC. IDENTIFIC. NUMBER

QUANTITY DISPENSED

DISPENSED BY

CHECKED BY RUNNING TOTAL

QUANTITY OF RETURNS

DATE RETURNED

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Study short title

      Ethics No.      

R&D No. RHM       Principal Investigator

     

Sponsor       Site      

FILE NOTE

Relates to Participant Code/Initials:

Describe event or issue, missing information/missing document and indicate whether follow-up required and by what time.

Date:

Completed by (staff initials):

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Study short title

      Ethics No.      

R&D No. RHM       Principal Investigator

     

Sponsor       Site      

TRAINING LOGSurname, First Name

      Role      

Activity Training appropriate

to role(please select)

Date training complete

Initials trainee

Initials trainer

Comments

Initiation Meeting Yes□ No□

Investigators brochure

Yes□ No□

Protocol training Yes□ No□

GCP training Yes□ No□

Telephone Screening Yes□ No□

Receiving Informed Consent Yes□ No□

Medical Assessment Yes□ No□

Data collection/ Measurements Yes□ No□

CRF entry Yes□ No□

Internal CRF Monitoring Yes□ No□

Drug Accountability Yes□ No□

Yes□ No□

Yes□ No□

Yes□ No□

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