Basic Document Catalogue Preserved of Medical Device Clinical Trial - Regulatory News - Medical Devices

CFDA has issued Good Clinical Practice for Medical Device with National Health and Family Planning Commission to strengthen the management of clinical trial of medical device on Mar 23th, 2016. This regulation will come into force from Jun 1st, 2016.

There are a large number of documents shall be kept up during clinical trial, and they are important for clinical trial inspection. If manufacturer prepares the document poorly, that will cause the clinical trial inspection failure.
So which the documents shall be prepared and how to preserve them?

Stage 1 clinical trial preparation

Basic Document Catalogue		Clinical trial institution	Sponsor
1	Researcher Manual	Preservation	preservation
2	Clinical trial project & Amendment(Signed)	Original preservation	Original preservation
3	Case Report Form	Preservation	Preservation
4	Qualification test report of tested medical device	Preservation	Preservation
5	Statement of GMP compliance for tested medical device	Preservation	Preservation
6	Quality assurance and control document of tested medical device during design and development	-	Original preservation
7	Informed consent document	Preservation	Preservation
8	Financial regulations	Preservation	Preservation
9	Clinical trial agreement or contract of clinical trial institution, researcher and sponsor (signed).	Original preservation	Original preservation
10	Review comment of Ethics committee	Original preservation	Preservation
11	Membership table of Ethics committee	Original preservation	Preservation
12	Clinical trial application (if any)	-	Original preservation
13	Laboratory document before clinical trial (if any)	-	Original preservation
14	Approval letter of China Food and Drug Administration (if any)	Preservation	Original preservation
15	Researcher resume & related document	Preservation	Original preservation
16	Normal value range of laboratory detection related to clinical trial	Preservation	Preservation
17	Quality control document of laboratory/medical operation (if any)	Original preservation	Preservation
18	Tested medical device label	-	Original preservation
19	Delivery receipt of tested medical device and goods related to clinical trial.	Preservation	Preservation
20	Tested medical device self-inspection report	-	Original preservation
21	Break procedure of blind test (if any)	-	Original preservation
22	Total randomize table (if any)	-	Original preservation
23	Supervision plan	-	Preservation
24	Clinical trial record document of China Food and Drug Administration	Preservation	Original preservation
25	Training record	Preservation	Preservation

Stage II Clinical trial implementation

Basic Document Catalogue		Clinical trial institution	Sponsor
26	Updated researcher manual (if any)	Preservation	Preservation
27	Other updated document (such as project, case report form, informed consent, written notice ) (if any)	Preservation	Preservation
28	Updated normal value range of medicine/laboratory inspection/operation (if any)	Preservation	Preservation
29	Delivery receipt of tested medical device and goods related clinical trial	Preservation	Preservation
30	Visited report of supervisor	Preservation	Original preservation
31	Signed Informed consent	Original preservation	-
32	Original medical records	Original preservation	-
33	Case report form (filled, signed, dating)	Original preservation	Preservation
34	Serious adverse event report by researcher (if any)	Original preservation	Preservation
35	Serious adverse event report and report of medical device defect which can cause serious adverse event by sponsor (if any)	Preservation	Original preservation
36	Subjects’ number table	Original preservation	-
37	Subjects’ screening form & eligible form	Preservation	-
38	Research’s signed sample and authorization form	Preservation	Preservation

Stage 3 clinical trial termination or completion

Basic Document Catalogue		Clinical trial institution	Sponsor
39	Dispose record of tested medical device	Preservation	Preservation
40	Code catalogue of subjects who finish the clinical trial	Preservation	Preservation
41	Supervision, review, and inspection record	Preservation	Original preservation
42	Final supervision report	-	Original preservation
43	Treatment distribution record	Preservation	Original preservation
44	Break blind proof (if any)	Preservation	Original preservation
45	Clinical trial summary or clinical trial report	Original preservation	Original preservation

Ms. Windy Jin,
Medical Device Legislation Compliance Deportment, CIRS China;
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Email: Windy@cirs-group.com

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