/ Trial
Site Master File Index

* denotes document should be retained according to MRC-GCP guidelines

Section 1: Grant Information – Not Applicable
Section 2: Protocol / Principal Investigator / Present
Y / N / n/a
2.1 / Current approved protocol
Version number: _____ Date: ______ / Copy*
2.2 / Previous approved versions of protocol
Version number: _____ Date: ______
Version number: _____ Date: ______ / Copy*
(if relevant to site)
2.3 / Version Log/Trial History Log / Copy
Section 3: Information for Participants
3.1 / Current approved patient information sheet
Version number: _____ Date: ______ / Copy*
Previous approved versions of patient information sheet
Version number: _____ Date: ______
Version number: _____ Date: ______ / Copy*
(if relevant to site)
3.2 / Current approved consent form
Version number: _____ Date: ______ / Copy*
Previous approved versions of consent form
Version number: _____ Date: ______
Version number: _____ Date: ______ / Copy*
(if relevant to site)
3.3 / Translations of Patient Information Sheet and Consent Forms / Copy
3.4 / Version Log / Copy
3.5 / Advertisements for patient recruitment and any amendments / Copy*
3.6 / Letter/information for a patient’s GP/consultant / Copy
3.7 / Any other written information given to patients / Copy
Section 4: Main Ethics / Principal Investigator / Present
Y / N / n/a
4.1 / MREC approval for protocol and supporting documentation / Copy
MREC committee composition / Copy
4.2 / MREC approval of protocol amendments / Copy
(if relevantto site)
4.3 / Interim or Annual reports to ethics committee / Copy
4.4 / Final report to ethics committee / Copy
Section 5: Regulatory (if applicable) / Principal Investigator / Present
Y / N / n/a
5.1 / Regulatory approval / Copy*
5.2 / Regulatory approval of protocol amendments / Copy
(if relevantto site)
5.3 / Interim or Annual reports to regulatory authority / Copy
5.4 / Final report to regulatory authority / Copy
Section 6: Individual Site Information and Approvals / Principal Investigator / Present
Y / N / n/a
6.1 / Feasibility Questionnaire/ Pre-trial monitoring report/letter / Copy
6.2 / Principal Investigator CV (signed and dated)
CVs for other site staff (signed and dated) / Copy*
Copy
6.3 / NHS R&D application form (SSI)
NHS R&D approval letter
CSP documentation (if applicable) / Copy
Original
Copy
6.4 / Site Agreement / Copy
6.5 / Other applications/approvals (e.g. ARSAC) / Original
6.6 / Delegation and responsibilities signature log / Copy*
6.7 / Trial initiation monitoring report/letter
Monitoring visit reports/letters
Final Trial Close-Out Monitoring Report/letters
Relevant communications (e.g. letters, meeting notes, notes of telephone calls) / Original*
Original*
Original*
Original*
Section 7: Study Drugs (if applicable) / Principal Investigator / Present
Y / N / n/a
7.1 / List of pharmacy contacts / Copy*
7.2 / Investigator Brochure or Summary of Product Characteristics for marketed products and any updates
Version number: _____ Date: ______
Version number: _____ Date: ______ / Copy*
7.3 / Sample of label(s) attached to Investigational Product containers / Copy*
7.4 / Instructions for handling of investigational products(s) and trial related materials (if not included in protocol or investigator brochure) / Copy*
7.5 / Shipping records for investigational product(s) / Copy
7.6 / Investigational product accountability at site / Copy
7.7 / Documentation of investigational product destruction / Copy
7.8 / Decoding procedures for blinded trials / Copy
Section 8: Laboratory (if applicable) / Principal Investigator / Present
Y / N / n/a
8.1 / Normal value(s)/ranges(s) for tests (dated) / Copy*
Changes to normal value(s)/range(s) (incl change date) / Copy*
8.2 / Laboratory certification, accreditation and/or quality control documentation / Copy
Changes to laboratory certification, accreditation and/or quality control documentation / Copy
8.3 / Record of retained body fluids/tissue samples / Original*
Section 9: Monitoring - Not Applicable
Section 10: General Site Information / Principal Investigator / Present
Y / N / n/a
10.1 / List of Investigators & updates / Copy*
10.2 / Study specific training documentation / certificates/evidence / Original
Section 11: Data Collection / Principal Investigator / Present
Y / N / n/a
11.1 / Subject screening log / enrolment log / Original*
11.2 / Signed informed consent forms / Original*
11.3 / Source documents / Original
11.4 / Sample Case Report Form & amendments / Copy*
11.5 / Sample of Patient Questionnaire(s) & amendments / Copy
11.6 / Signed, dated and completed CRFs / Copy*
11.7 / Documentation of CRF corrections / Copy*
Section 12: Safety Information / Principal Investigator / Present
Y / N / n/a
12.1 / Serious Adverse Event forms and related correspondence (if not included in CRF) / Copy*
12.4 / Notification by Sponsor to investigators of new safety information / Copy
Section 13: Results – Not applicable
Section 14: Programming Information – Not applicable
Section 15: Standard Operating Procedures – Not applicable

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Template 11-3: Site Master File Index

Version 1.2; 1 August 2011