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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

   The informed consent doctrine is generally implemented through good healthcare practice: pre-operation discussions with patients and the use of medical consent forms in hospitals. However, reliance on a signed form should not undermine the basis of the doctrine in giving the patient an opportunity to weigh and respond to the risk.

4. Clinical research coordinator - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_coordinator

   The sponsor sets informed consent requirements, as does the IRB. Each local IRB must review and approve the informed consent, but the CRC is responsible for communication between the IRB and the sponsor. §46.116 of the Code of Federal Regulations outlines the basic elements of informed consent as a: [5]

5. Clinical data management system - Wikipedia

   en.wikipedia.org/wiki/Clinical_data_management...

   A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.

6. Case report - Wikipedia

   en.wikipedia.org/wiki/Case_report

   In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.

7. Informed Consent in Medical Research - Wikipedia

   en.wikipedia.org/wiki/Informed_Consent_in...

   Informed Consent in Medical Research is a medical textbook on medical ethics, authored by Jeffrey S. Tobias and Len Doyal, and published by Wiley in 2001. It was produced in response to the debates between the authors in 1997, following the response to the 1990's British Medical Journal publications of studies in which consent was not obtained by participants.

8. Clinical research associate - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_associate

   A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with clinical research coordinators. [4] Clinical research associates also "ensure the protection of the rights, safety and well being of human study subjects."

9. Inclusion and exclusion criteria - Wikipedia

   en.wikipedia.org/wiki/Inclusion_and_exclusion...

   Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used for assessment of outcomes ...