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- 2. ĐỊNH NGHĨA • “Tài liệu thiết yếu (essential documents) là các tài liệu cho phép đánh giá quá trình thực hiện nghiên cứu và chất lượng của các số liệu thu được.” ICH Guidelines, section 8
- 3. MỤC ĐÍCH • Minh chứng việc tuân thủ các tiêu chuẩn của Thực hành Lâm sàng tốt và các đòi hỏi pháp chế hiện hành. • Giúp quản lý hiệu quả và thành công nghiên cứu lâm sàng. • Xác nhận tình đúng đắn của nghiên cứu và tính trung thực của số liệu thu được thông qua kiểm toán và thanh tra
- 4. TRƯỚC KHI TIẾN HÀNH NGHIÊN CỨU Phần lớn các tài liệu thiết yếu do ICH/GCP yêu cầu đều phải được lưu trong tập hồ sơ pháp lý tại điểm nghiên cứu
- 5. TRONG QUÁ TRÌNH NGHIÊN CỨU • Các tài liệu được cập nhật • Thư từ trao đổi và các báo cáo • Báo cáo các biến cố bất lợi • Tài liệu liên quan đến đối tượng tham gia nghiên cứu
- 6. SAU KHI KẾT THÚC NGHIÊN CỨU Các báo cáo tổng kết: Báo cáo giám sát kết thúc nghiên cứu Báo cáo của nghiên cứu viên gửi lên IRB/IEC
- 7. SAU KHI KẾT THÚC NGHIÊN CỨU (tiếp) • Báo cáo giải trình về sản phẩm nghiên cứu • Báo cáo nghiên cứu lâm sàng, nếu yêu cầu
- 8. LƯU TRỮ TÀI LIỆU THIẾT YẾU Trong bao lâu? CCP Ai chịu trách nhiệm ?
- 9. TÓM TẮT • Yêu cầu đối với cả nhà tài trợ và nghiên cứu viên • Thể hiện việc tuân thủ các quy định trong suốt quá trình nghiên cứu
Hinweis der Redaktion
- Before the Clinical Study Trial master file should be set up at the beginning of the trial, both at the investigator’s site and at the sponsor’s office. A final close-out of the trial can only be done when the monitor has reviewed both the investigator and sponsor files and confirmed that all necessary documents are in the appropriate files. ICH Guideline 8.2 identifies all documents that are needed to be on file prior to the start of a clinical study. Most of the documents you’re going to need for the study will have to be in place before the study starts- e.g. before you enroll a single participant, the CVs of the staff will need to be on file, the IRB approvals of the protocol will need to be on file, etc. Reference: ICH E6 Section 8.2 Phe duyet San pham NC Khoi dong (initiation) bat dau du an NC Essential Documents
- During the Clinical Study Section 8.3 of ICH/GCP lists essential documents expected to be added during the conduct of the study. These documents generally fall into these categories: Updates- Studies change as they go on!- e.g. protocol amendments, which result in changed ICFs and IRB approvals for both; updates to IBs, updates to CVs, updates to normal ranges etc Communication and reports including letters, meeting notes, annual reports to EC, monitoring reports etc For AE reporting- SAE notifications to the sponsor Participant related- additions to screening and enrollment log, signed ICFs, subject identification code list Important point- when we update a document- say a CV or an informed consent and add it to the regulatory files, do we throw out the old one? No! We save it! CVs are a great e.g.. imagine we have a study going from 2000 to 2006. I file my CV in 2000 but update it in 2003. In 2006 an inspector wants to see if I was really qualified to work with these patients back in 2001. He’ll want to be able to look at my old resume and see that I already had adequate training at that time. Reference: ICH E6 Section 8.3 Essential Documents
- After the Clinical Study ICH Guideline 8.4 identifies the documents needed after the completion or termination of the clinical study- there aren’t so many of them. Examples include the final product accountability and product destruction documentation (for studies where there is a product), Final report from the Invesitigator to the EC if required by the EC and to the regulatory authorities if required; also the final close-out monitoring report. After completion or termination of the study, all of the documents identified in Section 8.2, 8.3, and 8.4 should be in the file together. Note: Clinical study report is are the final report (once the study is complete or has been terminated) that is sent to the regulatory authority(ies) as required by applicable regulatory requirements. Reference: ICH E6 Section 8.4 Essential Documents
- Document Retention Per ICH/GCP, essential documents should be retained until at least two years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region, or at least two years have elapsed since the formal discontinuation of clinical development of the investigational product. Clearly these are ties specific to a drug/product trial However, these documents should be retained for a longer period, by an agreement with the sponsor or if required by the applicable regulatory requirements. It is the responsibility of the sponsor to inform the investigator/institution when these documents no longer need to be retained. This notification needs to be done in writing. The sponsor must also notify the investigator in writing when trial -related records are no longer needed. Reference: ICH E6 Section 4.9.5 Note FDA also has the 2 year period for the retention of essential docs, but the starting point for the two year period differs, i.e. it’s 2 years after a marketing application is approved for the drug or if the application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA has been so notified. Essential Documents
- Summary The sponsor and investigator must set up and maintain a study file in which essential documentation is kept. Monitors, auditors, and inspectors will use the study files to evaluate GCP and protocol compliance. Access to the study files needs to be controlled. Sponsor and investigator files should duplicate one another in that both sets of files have most of the same essential documents at the end of the study. Essential Documents