Chief Investigator: trial master file table of contents study Code: Eudract number



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Chief Investigator:
TRIAL MASTER FILE
TABLE OF CONTENTS


Study Code:

EudraCT Number:



Example index of required documents for the Trial Master File/Investigator Site File


SECTION

TITLE

COMMENT

One

Protocol and Associated Documents




1.1

Approved protocol and amendments




1.2

Approved Participant Information Sheet

and amendments if applicable

1.3

Approved Informed Consent Form

and amendments if applicable

1.4

Approved GP letter (if applicable)

and amendments if applicable

1.5

Approved advertisement (if applicable)

and amendments if applicable

1.6

Sample CRFs

and amendments if applicable

Two

Study Personnel




2.1

Contact details (including emergency contact)




2.2

Signed and dated Curriculum Vitae




2.3

Delegation of Authority and Signature Log




Three

Research Ethics Committee (REC)




3.1

REC application form




3.2

REC approval letter and composition




3.3

REC correspondence relating to amendments




3.4

Annual Progress Reports




3.5

Correspondence




Four

Regulatory




4.1

Regulatory application




4.2

Regulatory authorisations




4.3

Regulatory correspondence relating to amendments




4.4

Correspondence




Five

Sponsorship




5.1

Letter of Acceptance of Sponsorship




5.2

Division of Accountability

TMF only – not ISF, unless a single-centre study

Six

NHS Trust R&D (if applicable)




6.1

Approval letter(s)




6.2

Progress Report




6.3

Correspondence




Seven

Contracts & Agreements/Finance/Indemnity




7.1

Funding arrangements




7.2

Agreement between involved parties




7.3

Other agreements eg IMP supplier




7.4

Cheque request forms/invoices




7.5

Indemnity (if not covered in Agreement)




7.6

Correspondence




Eight

Safety Reporting




8.1

Investigator Brochure/Summary of Product Characteristics and updates




8.2

Serious Adverse Event (SAE) Reports




8.3

Suspected Unexpected Serious Adverse Reaction (SUSAR) reports




8.4

Developmental Safety Update Reports




8.5

Procedure for randomisation and unblinding/code break (if applicable)




8.6

Code break envelopes (if applicable)




8.7

Blank SAE forms




8.8

Correspondence




Nine

Monitoring




9.1

Monitoring Plan




9.2

Site Initiation Report (or equivalent)




9.3

Monitoring Visit Reports/Log




9.4

Study Close-out Report




9.5

Correspondence




Ten

Subject Logs and Consent Forms

ISF only – not TMF, unless a single-centre study

10.1

Subject Screeing and Enrolment Log, Identification Code List

ISF only – not TMF, unless a single-centre study

10.2

Signed Informed Consent Forms

ISF only – not TMF, unless a single-centre study

Eleven

Equipment (if applicable)




11.1

Calibration certificates




11.2

Related correspondence




Twelve

Audit (if applicable)




12.1

Audit report/certificate




12.2

Audit correspondence




Thirteen

Pharmacy (to be kept in pharmacy department whilst study is ongoing if using Pharmacy Services




13.1

Delegation of Authority and Signature Form




13.2

Pharmacy Agreement




13.3

Cheque request form/invoices




13.4

Documentation of shipment




13.5

Sample of labelling




13.6

Instructions for handling of IMP




13.7

Notification of unblinding




13.8

Retrieval of code-break envelopes




13.9

Drug accountability




13.10

Pharmacy correspondence




Fourteen

Local laboratory (if applicable)




14.1

Normal ranges




14.2

Accreditation




14.3

Sampling instructions/protocol




14.4

Laboratory correspondence




Fifteen

Other Local Service Providers




15.1

Correspondence




Sixteen

Study Report/Publication




16.1

Study Report/Publication




Seventeen

General Correspondence




17.1

Correspondence




Eighteen

File Notes















Template Trial Master File Table of Contents: Version 4.0 Page of

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