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2. Case report form - Wikipedia

   en.wikipedia.org/wiki/Case_report_form

   A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.

3. Informed consent - Wikipedia

   en.wikipedia.org/wiki/Informed_consent

   Example of informed consent document from the PARAMOUNT trial. Informed consent is a principle in medical ethics, medical law, media studies, and other fields, that a person must have sufficient information and understanding before making decisions about accepting risk, such as their medical care.

4. Dynamic consent - Wikipedia

   en.wikipedia.org/wiki/Dynamic_consent

   Dynamic consent is an approach to informed consent that enables on-going engagement and communication between individuals and the users and custodians of their data. It is designed to address the many issues that are raised by the use of digital technologies in research and clinical care that enable the wide-scale use, linkage, analysis and integration of diverse datasets and the use of AI and ...

5. Research participant - Wikipedia

   en.wikipedia.org/wiki/Research_participant

   A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A research participant is different from individuals who are not able to give informed consent, such as ...

6. Common Technical Document - Wikipedia

   en.wikipedia.org/wiki/Common_Technical_Document

   The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)

7. Research ethics - Wikipedia

   en.wikipedia.org/wiki/Research_ethics

   Research integrity or scientific integrity is an aspect of research ethics that deals with best practice or rules of professional practice of scientists.. First introduced in the 19th century by Charles Babbage, the concept of research integrity came to the fore in the late 1970s.