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:
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Current protocol
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Protocol amendments
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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:
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by Investigator to co-ordinating research body
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by co-ordinating research body to Investigator
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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.