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Basic Document Catalogue Preserved of Medical Device Clinical Trial

from CIRS by

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

Stage II Clinical trial implementation

Basic Document CatalogueClinical trial institutionSponsor
26Updated researcher manual (if any)PreservationPreservation
27Other updated document (such as project, case report form, informed consent, written notice ) (if any)PreservationPreservation
28Updated normal value range of medicine/laboratory inspection/operation (if any)PreservationPreservation
29Delivery receipt of tested medical device and goods related clinical trialPreservationPreservation
30Visited report of supervisorPreservationOriginal preservation
31Signed Informed consentOriginal preservation-
32Original medical recordsOriginal preservation-
33Case report form (filled, signed, dating)Original preservationPreservation
34Serious adverse event report by researcher (if any)Original preservationPreservation
35Serious adverse event report and report of medical device defect which can cause serious adverse event by sponsor (if any)PreservationOriginal preservation
36Subjects’ number tableOriginal preservation-
37Subjects’ screening form & eligible formPreservation-
38Research’s signed sample and authorization formPreservationPreservation
Stage 3 clinical trial termination or completion
Basic Document CatalogueClinical trial institutionSponsor
39Dispose record of tested medical devicePreservationPreservation
40Code catalogue of subjects who finish the clinical trialPreservationPreservation
41Supervision, review, and inspection recordPreservationOriginal preservation
42Final supervision report-Original preservation
43Treatment distribution recordPreservationOriginal preservation
44Break blind proof (if any)PreservationOriginal preservation
45Clinical trial summary or clinical trial reportOriginal preservationOriginal 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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