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The Informed Consent Form and the Medical Monitor
The medical monitor assigned to the study should review the trial-specific master Informed Consent Form (ICF). This review should ensure that all essential elements of informed consent are mentioned in clear language that would be understandable to the target patient population (as per applicable regulations, such as FDA’s 21 CFR 50.25 and ICH E6).
It is the responsibility of the medical monitor to ensure that the following information is clearly communicated via the ICF:
- All relevant information regarding the investigational nature of the trial,
- The probability of receiving study treatment in case of placebo-controlled studies,
- Safety information regarding the study drug,
- That participation is voluntary and refusal to participate does not impact in any way the standard of care the patient would be receiving,
- The risks involved in participation,
- The other treatment options available for the underlying disease,
- The right to opt out of the study at any time with no impact on the standard of care that the patient would be receiving.
Special attention should be paid to the contents of the ICF and the intended procedures for obtaining informed consent in studies that plan on recruiting patients from vulnerable groups such as pediatric trials. When the participants are less than the legal age for consent the ICF would be signed by the parents or legal guardian and in trials where the subjects may have cognitive deficits that cause diminished consent capability, a legally acceptable representative can provide consent on behalf of subjects. This is referred to as surrogate consent.
Based on our experience, it is also important to foresee that a review is performed by a medically qualified person for ICF documents translated into languages other than that of the master ICF. This is to ensure that the contents and the lay language used matches the contents of the master ICF from a medical and scientific perspective.
CFR – Code of Federal Regulations Title 21: Website (Accessed: 24 NOV 2020)
Guideline for good clinical practice E6(R2): Online PDF (Accessed: 24 NOV 2020)
Mohamed El Malt, MD, PhD and Vijayanand Rajendran, MD. (2016) Medical management in clinical trials: A roadmap to operational excellence. Journal for Clinical Studies 8(2): 28-33
Medical Management in Clinical Trials:
A Roadmap to Operational Excellence
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