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Suggested investigator site file contents

 

Contents

Suggested Investigator Site File Contents

SECTION

TITLE

CONTENT/COMMENTS

SIGN & DATE WHEN COMPLETE

1

Protocol / amendments

Current protocol

Protocol amendments

Historical protocols

 

2

Sample CRF/

QLQ Diary Cards

If too bulky to put in file place file note in this section stating where it can be found

 

3

Regulatory approval

documentation

 

 

4

Site signature /responsibility log

 

 

 

5

Curriculum Vitae

CVs for all research personnel listed in the signature/responsibility log

 

6

Patient Identification form

Patient recruitment /screening form

 

 

7

Sample of current and all historical Patient Information / Informed Consent form and GP Letter

Completed patient Information and Informed Consent Forms

 

 

8

Correspondence

File in chronological order all correspondence to/from the coordinating research body. File email communication

Include a separate section here for newsletters

 

9

Minutes from Initiation meeting

Monitoring logs

Notes of telephone calls

If the study is not monitored state this in a file note in this section

Document telephone call in relation to agreements or significant discussions regarding trial administration, trial conduct, adverse events or protocol violations

 

10

Blank serious adverse event forms and guidelines for their completion

 

 

11

Notification of serious adverse events and/or safety reports

By Investigator to co-ordinating research body

By co-ordinating research body to Investigator

By co-ordinating research body to regulatory authorities (if this will not be supplied place a file note stating this)

 

12

Randomisation details

Instructions (if applicable)

 

13

Instructions for handling trial medication and trial related materials

Shipping records

This responsibility is normally that of the clinical trial pharmacist if this is the case place a file note in this section stating this

 

 

 


14

Clinical Laboratory

Laboratory normal reference ranges (including revisions)

Laboratory certificate(s)

 

15

Contracts

Investigator Commitment Statement/Study Acknowledgement

Indemnity

Confidentiality

Clinical Trial Agreement including financial details.

Completed and signed FDA 1572 form (if applicable)

Financial disclosure letter (if applicable)

 

16

Investigator’s Brochure

Safety alert letters/Updates

 

 

 

17

Completed Data Queries

 

 

 

18

Study Training Materials

 

 

 

19

Miscellaneous (specify)…….

 

 

 

 

AFTER THE COMPLETION OF THE TRIAL THE FOLLOWING MUST BE ALSO FILED IN THE SITE FILE

 

20

Investigational product(s) accountability at site

This will be with the clinical trials pharmacist

 

21

Documentation of Investigational product destruction

If destroyed at site this will be with the clinical trials pharmacist

 

22

Final report

From Investigator to REC

 

 

23

Clinical study report

To document results and interpretation of trial