1 | Investigator’s Brochure |
2 | CRF Case Report Form |
3 | Information Given to Trial Subject |
4 | Financial Aspects of the Trial |
5 | Insurance Statement |
6 | Signed Agreement between Involved Parties (sponsor/CRO/Investigator/Institution/Authories) |
7 | IRB Approval Original Document |
8 | IRB Composition List (Staff List) |
9 | FDA Authorisazion/ Approval |
10 | Curriculum Vitae or Other Evidencing Qualification Investigator |
11 | Normal Values/Range/Procedure (Any standardized operation procedure) |
12 | Medical Quality (Quality procedure in trail) |
13 | Device Labels for Investigation |
14 | Shipping Records for Investigational Device |
15 | Certificate of Analysis （CoA） |
16 | Decoding Procedures for Blinded Trials |
17 | Master Randomization List |
18 | (Pre-trial) Monitoring Report |
19 | Trial Initiation Monitoring Report |
20 | If applicable, Investigator’s Brochure Updates do you have procedure. |
21 | If applicable, amendments for CRF form |
22 | If applicable, IRB/IEC’s amendments |
23 | Sites Visit Reports |
24 | Signed Information Consent Forms |
25 | Serious Adverse Events/ Related Reports |
26 | Notification from sponsor or investigators of safety information |
27 | Interim or annual reports provided to IRB/IEC |
28 | Subject Screening Log |
29 | Subject Identification Code List |
30 | Subject Enrolment Log |
31 | Signature Sheet for CRF including Correction |
32 | If any trial repeated on one subject location, Please make the record. |
33 | Investigational Product Accountability FOR EACH SITE |
34 | Device Destruction Record |
35 | Completed Subject Identification Code List |
36 | Audit Record If Exists |
37 | Final Trial Close-out Monitoring Report |
