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