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.
Protocol / amendments - to include:
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.
Regulatory approval documentation
Site signature /responsibility log
Note: CVs for all research personnel listed in the signature/responsibility log should be included.
Patient Identification form and Patient recruitment /screening form
Sample of current and all historical Patient Information / Informed Consent form and GP Letter.
Completed patient Information and Informed Consent Forms.
Note: File in chronological order all correspondence to/from the coordinating research body. File email communication. Include a separate section here for newsletters.
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.
Blank serious adverse event forms and guidelines for their completion.
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).
Note: to include instructions (if applicable)
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.
- Laboratory normal reference ranges (including revisions)
- Laboratory certificate(s)
- Investigator Commitment Statement/Study Acknowledgement
- Clinical Trial Agreement including financial details.
- Completed and signed FDA 1572 form (if applicable)
- Financial disclosure letter (if applicable)
Investigator’s brochure and safety alert letters/Updates
Completed data queries
Study training materials
After the completion of the trial
The following must also be filed in the site file:
Investigational product(s) accountability at site.
Note: This will be with the clinical trials pharmacist.
Documentation of Investigational product destruction.
Note: If destroyed at site this will be with the clinical trials pharmacist.
Final report from Investigator to REC.
Clinical study report to document results and interpretation of trial.