CLINICAL TRIALS DCUMENTATION .pptx

CT

1. CLINICAL TRIAL DOCUMENTATION 8/9/2024 1

2. CLINICAL TRIAL 8/9/2024 2

3. DIFFERENT PHASES OF CLINICAL TRIALS 8/9/2024 3

4. CLINICAL TRIAL DOCUMENTATION 8/9/2024 4

5. TRIAL MASTER FILE (TMF) 8/9/2024 5

6. SOURCE DOCUMENTS Original documents , data ,and records. Generally confidential. After the end of the trial period , these docs must be archived for a long time. ICH guidelines E6 states “essential documents should be retained until at least 2 yrs after last approval of a marketing application in an ICH region”. 8/9/2024 6

7. ESSENTIAL DOCUMENTS Essential documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents are serve to demonstrate the compliance of the investigator , sponsor ,and monitor with standards of good clinical practice and with all applicable regulatory requirements. These documents are also the ones which are usually audited by the sponsor’s independent audit function and inspected by regulatory authority as part of process to confirm the validity of trial and integrity of data collected. 8/9/2024 7

8. ESSENTIAL DOCUMENTS FOR CLINICAL TRIALS Investigator’s brochure Clinical study protocol Case report form Informed consent form Clinical study reports 8/9/2024 8

9. INVESTIGATOR’S BROCHURE(IB) 8/9/2024 9

10. CLINICAL STUDY PROTOCOLS 8/9/2024 10

11. DECLARATION OF HELSINKI 8/9/2024 11

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14. PARTS OF PROTOCOL 8/9/2024 14

15. CASE REPORT FORM(CRF) CRF is a paper or electronic document designed to record all the information for an individual study subject required by the study protocol. CRF should includes Study title and number Investigator’s name Study subject/ patients ID Inclusion/exclusion criteria Demographic data 8/9/2024 15

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17. INFORMED CONSENT 8/9/2024 17

18. MONITORING IN CLIICAL TRIALS 8/9/2024 18 PURPOSES The right and wellbeing of human subject are protected. The reported trials data are accurate, complete , and verifiable from source documents. The conduct of the trial follows the currently approved protocol/amendment with GCP and with applicable regulatory requirements.

19. SELECTION AND QUALIFICATIOS 8/9/2024 19

20. MONITOR REPORT 8/9/2024 20

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