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- https://ichgcp.net/clarification-of-certain-investigator-responsibilities
- 1. Reasonable Medical Care Necessitated by Participation in a Clinical Trial During a subject's participation in a trial, the investigator (or designated subinvestigator) should ensure that reasonable medical care is provided to a subject for any …
Basics About Clinical Trials | FDA
- https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials
- Clinical trials are conducted for many reasons: to determine whether a new drug or device is safe and effective for people to use. to study different ways to use standard treatments …
4. INVESTIGATOR: ICH E6 (R2) Good clinical practice
- https://ichgcp.net/4-investigator
- 4.8.12 When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the trial with the consent of the subject’s legally acceptable …
Clinical research versus patient care: Conducting clinical …
- https://www.ama-assn.org/delivering-care/ethics/clinical-research-versus-patient-care-conducting-clinical-trials
- Patients, and physicians on their behalf, may be tempted to overlook the “experimental” status of treatments under study and see enrollment in a clinical trial as a …
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