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 |
|
|
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 |
|