GE02-H I. Archiving of Clinical Trial Documents

Transcription

1 GE02-H I Archiving of Clinical Trial Documents Version: Final 01 Valid from: Replaces Version: Draft 09 of: Author: A. Ripkens-Reinhard Date Author signature Review: FG-QS Date FG QS spokesperson Approval: Board AG Date Board spokesperson Target group: All Coordination Centres for Clinical Trials Appendices: GE02-H-A1 GE02-H-A2 GE02-H-A3 GE02-H-A4 Information for the Investigator Information for the Sponsor Archiving Obligations According to the Medical Device Law Archiving Obligations According to the Radiation Protectionand X-ray-Regulation Contents Page 1 Objective Background Processes Assuming Archiving Obligations Proceedings of Acting as the Sponsor Acceptance of Request for Archiving from the Sponsor Requirements of an General Establishment of a Cooperation with an External Archiving References Changes from Last Version...6

2 1 Objective Aim of the Standard Operating Procedure (SOP) is to set a quality standard for of clinical trial documents. This SOP is limited to of paper-based documents. 2 Background Relevant clinical trial documents have to be stored over an adequate time period to have them available for audits and inspections. The ICH-GCP guideline (chapters 2.10, 4.9.5, ), the German Drug Law (AMG) as amended by the 12 th amending law (GCP regulation according to 42 (3) AMG 13(10); Arzneimittelprüfrichtlinie according to 26 AMG, chapter 4 B2) define the obligations for clinical trial documents. Responsible for is the investigator (see appendix 1), the sponsor or the party holding a marketing authorization or aiming for a marketing authorization (see appendix 2). Regulations for clinical trials using medical devices are to be found in the Medical Device Law (MPG), 20 and 24. The Radiation Protection Regulation (StrlSchV), 87 and the X-ray Regulation (RöV), 28c describe additional obligations for trials using ionizing radiation and X-rays. The following table summarizes the current regulations regarding the minimum time periods for. If different time periods equally apply, always the longest time period has to be observed. Legal requirements in Germany: GCP regulation according to 42 AMG (applies for all clinical trials using drugs, other regulations regarding of medicinal documents will remain unaffected) All relevant clinical trial documents including Case Report Forms 10 years after end or early termination of the clinical trial Sponsor, investigator (at sponsor s instance) Arzneimittelprüfrichtlinie according to 26 AMG (applies for clinical trials using drugs which results are used for application for marketing authorization) Patient s records and source data Patient identification list Longest possible time period allowed by the hospital, institution, or the private practice 15 years after end or early termination of the clinical trial Investigator (at sponsor s or subsequent holder s of marketing authorization instance) All clinical trial documents (TMF) As long as the drug is approved Sponsor or subsequent holder of marketing authorization Clinical trial report Another 5 years after end of approval of the drug - 2 of

3 X-ray Regulation (RöV); (applies for clinical trials using X-rays for medical research in humans) See RöV 28c or appendix 4 30 years Holder of approval according to RöV 28a Radiation Protection Regulation (applies for clinical trials using radio-active substances or ionizing radiation for medical research in humans) See StrlSchV 87 or appendix 4 30 years Holder of approval according to StrlSchV 23a Medical Device Law 12 (applies for clinical trials using medical devices) Medical device Active implantible medical device Other medical devices In vitro diagnostics International guidelines: See guideline 90/385/ EWG, appendix 6, Nr. 2.2 or appendix 3 See guideline 93/42/EWG, appendix VIII, Nr. 2.2 or appendix 3 See guideline 98/79/EG, appendix VIII, Nr. 2 or appendix 3 10 years Sponsor of a clinical trial 5 years Sponsor of a clinical trial 5 years Sponsor of performance assessment The ICH-GCP guideline defines a minimum time period for documents from clinical trials using drugs and refers to the respective national regulations of the countries in which marketing authorization exists or is aimed at (see appendices 1 and 2). 3 Processes The following procedures described refer to clinical trials on drugs. For other clinical trials, the procedures apply analogously. 3.1 Assuming Archiving Obligations The assumes compulsory in the following cases: 1. as the sponsor of a clinical trial extended obligations of a sponsor intending or holding marketing authorization are not considered. 2. by request of a sponsor Proceedings of Acting as the Sponsor If the acts as the sponsor of a clinical trial, the appropriate is responsible for filing trial-related documentation in the Trial Master File (TMF); (see SOP Trial Master File ). The investigator should be committed to store documents within the scope of the investigator s contract and/or the clinical trial protocol (see SOP Preparation of a Clinical - 3 of

4 Trial Protocol ). The monitor briefs the investigator to file all trial-related documents in the Investigator Site File (ISF) and states the relevant storage time (see SOP Investigator Site File and Close-Out Visit ). In particular, it should be pointed out that the subject identification list has to be stored for 15 years. Patient s records and source data have to be stored for the longest time that the hospital, institute or the private practice allows. The sends a written information to the investigator if the documents are no longer needed. After end or early termination of the clinical trial, the checks the TMF regarding completeness, prepares the documents for and hands over the documents including the request for stating the minimum time for to the archive representative (see 3.3). The archive representative (see 3.2.2) assures that the documents are archived according to the request for (see 3.3) The enterpriser who plans to use the trial data to get marketing authorization is responsible for of documents. In such case, handling of documents is agreed on by contract. The head of is responsible for the contract. If documents are handed over to other parties for, the is responsible for the handover and the filing of the transfer documents in the trial-related documentation remaining in the. Monitor The archive representative is responsible for hand out of documents from the archive to third parties (see 3.3). The transfer documents are stored in the archive documentation and in the trial-related documentation remaining in the Acceptance of Request for Archiving from the Sponsor Request for should be agreed by contract. The time period for is stated explicitly. Furthermore, handling of documents after the agreed time of has to be defined. 3.2 Requirements of an General - The archive must be lockable. - Access authorization must be arranged explicitly. Access to archive is only allowed for authorized persons. - Documents in the archive must be protected against water, fire, and unauthorized access. This has to be assured by appropriate measures. - d documents are indexed to allow duly storage and quick retrieval Establishment of a - - All general requirements for an archive described above have to be complied with. - An archive representative must be named. - The regulation for authorized access has to be filed in the archive documentation. - 4 of

5 - The name of the archive representative, his/her deputy and the time period of responsibility is laid down in the archive documentation. The responsible persons sign this document. - The archive documentation contains information about storage, stock, periods for, and withdrawal of documents Cooperation with an External Trial documents may be stored in an external archive if this archive fulfils the general requirements described above. The overall responsibility for of documents remains always with the sponsor. A written agreement has to be taken out with the head of the external archive in which - the archive representative is named as the contact person. - a responsible person/representative of the external archive is named. - it is assured that the general archive requirements mentioned above are fulfilled (see 5.2.1). - regulation of access is described. - organizational procedures (placing of orders, confirmation of etc.) for a single process is described. - it is assured that archived materials are available without delay in case of request for inspections. The agreement is filed in the archive documentation of the (if necessary as copy). All processes are conducted in agreement with the archive representative of the. - The archive documentation of the contains information about the archive representative and his/her deputy including the respective period of service. The responsible persons sign this documentation (signature and identification code). - Documents related to processes (request for storage, request for withdrawal, documentation related to performance etc.) are stored in the archive documentation of the. 3.3 Archiving Preconditions for of trial documents: - A written request for must be available containing - identifying specifications of the trial - identifying specifications of the client - specification of time period for - signature of client - list of documents/binders to be stored. - The documents/binders have to be labelled clearly (example see SOP Trial Master File ). The is responsible for the complete transfer of documents. The archive representative is responsible for the archive documentation. Storage: - archive: Storage of documents/binders according to local systematics and documentation of storage in the inventory - 5 of

6 External archive: Processing of request for - Filing of request for in the archive documentation - Return of acknowledgment of to the client (copy remains in the archive documentation). archive: The archive representative checks according to the defined rules access to the archive, required inspection of archived documents and withdrawal of documents. The archive representative controls the time periods for for each individual trial. Before the expiration date, the archive representative announces the upcoming destruction or return of documents according to the agreement to the client. If the client does not object, it is proceeded according to the agreement. If archived documents are returned, the client has to acknowledge receipt of the documents. The receipt is stored in the archive documentation. If documents are destroyed on request of the sponsor, a copy of the confirmation of destruction has to be filed in the archive documentation; the original is handed over to the sponsor. 4 References See reference list of the working group Quality Assurance of the -AG 5 Changes from Last Version None first version - 6 of