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Informed consent Documents / Forms, Case Report /Record Form, Investigators Brochure, Study Protocol, Clinical Trial Documents, Life Sciences, BioStatistics.

Connect with me on LinkedIn @https://www.linkedin.com/in/jain-vidit/
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Esssential documnets in clinical trial

  1. 1. ESSENTIAL DOCUMENTS IN CLINICAL TRAILS
  2. 2. INFOMED CONSENT DOCUMENTS CASE REPORT/RECORD FORM INVESIGATORS BROCHURE 01 02 03 Table Of Contents
  3. 3. Informed Consent Documents It is a legal and ethically obligated written agreement that every clinical practitioner must provide to potential participants that explains information such as :  Purpose of study  Treatment procedure and schedule  Potential risks & benefits  Alternatives to participation  Individual’s rights as a Subject. In a language that could be read and understood by the volunteer and is to be Signed by the volunteer or his/hers legal representatives, which would indicate that the research participant has decided to take part in the research of her/his own free will. It is also known as Informed Consent forms.
  4. 4. What ICDs Must Include According to the World Health Organization's Ethics Review Committee( WHO ERC) template for ICD The informed consent form consists of two parts: the information sheet and the consent certificate which includes 1.Introduction 2.Purpose of Study 3.Type of Research Interventions, Duration 4.Participant Selection Criteria 5.Voluntary Participation 9.Confidentiality 8. Benefits & Reimbursement 6.Information on Trial Drugs 7.Procedure & Protocol
  5. 5. Why Do We Need ICDs o It informs the participants about the trial and lets them make educated decisions about taking part in the study. o Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action. o No one can guarantee positive outcomes in healthcare settings, but informed consent at least ensures patients understand the risks they undertake with treatment. It is also the law. When patients agree to a treatment, they must sign paperwork indicating they understand the risks and agreeing doctors can take specific life-saving measures if needed. SEVERE LAPSES IN COVAXIN TRIALS IN BHOPAL, CONSENT FORMS NOT GIVEN; PARTICIPANTS WHO FELL ILL NOT TREATED Source: https://www.nationalheraldindia.com/india/severe-lapses-in-covaxin-trials-in-bhopal-consent- forms-not-given-participants-who-fell-ill-not-treated Several participants complained they were not informed that they were participating in COVID-19 vaccine trials. Those who fell ill after being administered the vaccine were told to pay for treatment SEVERE LAPSES IN COVAXIN TRIALS IN BHOPAL; CONSENT FORMS NOT GIVEN, PARTICIPANTS WHO FELL ILL NOT TREATED 07 Jan 2021, 8:10 AM
  6. 6. Why Do We Need ICDs o It informs the participants about the trial and lets them make educated decisions about taking part in the study. o Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action. o No one can guarantee positive outcomes in healthcare settings, but informed consent at least ensures patients understand the risks they undertake with treatment. It is also the law. When patients agree to a treatment, they must sign paperwork indicating they understand the risks and agreeing doctors can take specific life-saving measures if needed.
  7. 7. Case report form (CRF) is a specialized document in clinical research which could be a printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. for accurate input presentation ,verification ,audit and inspection of the recorded data. It could be a handwritten one-time snapshot of Participant’s physical condition or hundreds of pages of electronically captured data obtained over a period of weeks or months. Before sending the CRF to sponsor, identification details are removed, and a unique study number is given to each participant. Case Report/Record Forms
  8. 8. Purpose of CRF Capturing all protocol- required information Facilitates data collection and entry, Benefits data management and statistical analysis. Promote data sharing between the study team and other institutions 1 2. 3.
  9. 9. The Investigator’s Brochure (IB) is a compilation of the information on clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in methods of administration, safety monitoring, and human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. It must include information on sponsor’s name and identity of the product and also the background information on the properties and history of investigational medicinal product. Investigator’s Brochure
  10. 10. Effects in Humans Introduction Physical, Chemical, And Pharmaceutical Properties and Formulation Summary Contents Of Investigator’s Brochure Non-Clinical Studies Summary of data And Guidance for the Investigator Confidentiality Statement
  11. 11. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik. THANKS! Do you have any questions? PRESENTED BY VIDIT JAIN
  • SushamaSinha2

    Oct. 21, 2021
  • NadeemAkram37

    Sep. 22, 2021

Informed consent Documents / Forms, Case Report /Record Form, Investigators Brochure, Study Protocol, Clinical Trial Documents, Life Sciences, BioStatistics. Connect with me on LinkedIn @https://www.linkedin.com/in/jain-vidit/ If you need any help with this presentation 

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