Clinical Researchs regulations

Clinical research regulations are set in place to make sure that all clinical researches are conducted in accordance with international principles. The following regulations are the basics of the clinical research profession.

Good Manufacturing Practice (GMP)

This regulation is set in place to manufacture investigational medications and products to meet up to standard. This ensures that all participants involved in the clinical trials are not exposed to poor, harmful, and ineffective drugs.

Good Clinical Practice (GCP)

Good clinical practice is a major regulation that is set in place to conduct all clinical trials in accordance with the internationally recognized principles of the ICH GCP. It is there to ensure that risks to patients and volunteers are minimized.

Good Clinical Practice and Good Manufacturing Practice inspections and Enforcement

The MHRA checks the principles and standards of the GMP and GCP to ensure that quality and compliance are followed. They also help identify non-compliance and also provides enforcement power.

Incapacitated Adult's Protection

This regulation is set in place to protect adults that are incapable of giving informed consent e.g advanced Alzheimer's disease. The decision to consent to, refuse, or participate in a trial is made by an independent "consultee" that would act on the basis of the incapacitated adult wishes.

Minor's Protection

This regulation is set in place to protect minors (persons under the age of 16) and ensure that the following provisions are catered to:

  • REC consideration of receiving advice on the pediatric care relevant field.

  • A parent, custodian, guardian, or legal representative must give informed consent.

  • The minors should be informed of the risks and benefits of the trial according to their understanding capacity by staff experienced with young people.

  • The minor's wishes to be withdrawn from the trial or refusal to participate from the trial should be considered.

  • The clinical trial must be directly related to the illnesses the minor suffers from.

  • The clinical trial must directly benefit the minor involved.

Pharmacovigilance Arrangements

This regulation takes into account all the clinical trials of an IMP and ensures that the reviews of adverse events and processing of serious adverse events are reported immediately to sponsors. There must also be a record for suspected unexpected serious adverse reactions caused by the trial medicines and they must be reported to the MHRA.

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