Suggested investigator site file contents

The following documentation and structure is suggested for investigator site files. We recommend that you include a content page and sign and date when each section is complete.

Section 1

Protocol / amendments - to include:

Current protocol
Protocol amendments
Historical protocols

Section 2

Sample CRF/ QLQ Diary Cards

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

Section 3

Regulatory approval documentation

Section 4

Site signature /responsibility log

Section 5

Curriculum Vitae

Note: CVs for all research personnel listed in the signature/responsibility log should be included.

Section 6

Patient Identification form and Patient recruitment /screening form

Section 7

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

Completed patient Information and Informed Consent Forms.

Section 8

Correspondence

Note: File in chronological order all correspondence to/from the coordinating research body. File email communication. Include a separate section here for newsletters.

Section 9

Minutes from the initiation meeting, monitoring logs and notes of telephone calls.

Note: If the study is not monitored then 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.

Section 10

Blank serious adverse event forms and guidelines for their completion.

Section 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).

Section 12

Randomisation details

Note: to include instructions (if applicable)

Section 13

Instructions for handling trial medication and trial related materials and shipping records.

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

Section 14

Clinical Laboratory:

Laboratory normal reference ranges (including revisions)
Laboratory certificate(s)

Section 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)

Section 16

Investigator’s brochure and safety alert letters/Updates

Section 17

Completed data queries

Section 18

Study training materials

Section 19

Miscellaneous (specify).

After the completion of the trial

The following must also be filed in the site file:

Section 20

Investigational product(s) accountability at site.

Note: This will be with the clinical trials pharmacist.

Section 21

Documentation of Investigational product destruction.

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

Section 22

Final report from Investigator to REC.

Section 23

Clinical study report to document results and interpretation of trial.