Protocol and CRF in clinical trials.pptx

Protocol and CRF in clinical trials

1. PROTOCOL & CASE REPORT FORM (CRF) IN CLINICAL TRIALS 445 AMIT PAL

2. PROTOCOL IN CLINICAL TRIALS Introduction Protocol is a pivotal document in clinical trial. All the different steps that has to be conducted during clinical trial is documented properly in the protocol.

3. PROTOCOL IN CLINICAL TRIALS The protocol contains a study plan on which the clinical trail is based. It is designed in such a way that it safeguards the health of the participants and also answer the specific questions. It lays out who, what, why, when, where and how about the clinical trials. It safeguards clinical trails integrity. The protocol describes, what types of people may participate in the trial, the schedule of the tests, procedure, medication, dosages and length of the study.

4. Protocol contents Background – name and/or identity, chemical composition of the investigational drug, current status of the disease or condition. Trial objective and purpose – specific aim of study Study design – The scientific integrity of the trail and the credibility of the data from the trail depend substantially on the trial design. This Photo by Unknown Author is licensed under CC BY

5. Protocol contents Selection and Withdrawal of Subjects – This includes subject inclusion and withdrawal criteria. Safety and Efficacy Assessments Adverse event reporting - AE recording and its requirements, reporting to regulatory authority, Withdrawal of subjects due to AE, etc. This Photo by Unknown Author is licensed under CC BY-NC-ND

6. Protocol contents Statistical methods/data analysis – Consists of statistical data analysis of the CT. Quality control and Quality Assurance – Description of nature and timing of the quality control/assurance reviews Data handling and record keeping – Data recording/case reports form, record maintenance and retention.

7. Protocol contents Ethics: Institutional review board (IRB) approval Ethical and scientific conduct of the clinical research study. Subject informed consent Study discontinuation criteria – Details on discontinuation of individuals research subjects. This Photo by Unknown Author is licensed under CC BY-SA

8. CASE REPORT FORM (CRF) CRF is a paper or electronic questionnaire specifically used in clinical trial research

9. CASE REPORT FORM (CRF) Is the tool to collect data from each subjects enrolled from different sites. This Photo by Unknown Author is licensed under CC BY-SA

10. CASE REPORT FORM (CRF) The sponsor of the clinical trail develops the CRF to collect the specific data they need in order to test the hypotheses or answer specific research questions This Photo by Unknown Author is licensed under CC BY

11. Why use a CRF? Accuracy Consistency Completeness Clarity: provide definitions and details Easy exchange data Provides increased efficiency in processing and analysis of data

12. THANK YOU !