Clinical trials vary widely in scale, complexity and cost. Careful evaluation of critical to quality factors involved in each trial and the risks associated with these factors will help ensure efficiency by …

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Additional import and export controls under the Health Products (Therapeutic Products) Regulations 2016 and the Misuse of Drugs Regulations are applicable to clinical trials using clinical research …

Notice Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, changes in treatment and drug therapy are required.

The Four Phases of Clinical Trials ... Association of Clinical Research Professionals | acrpnet.org Page 1 of 1

These interventions may be medical products, such as drugs or devices, procedures, or changes to participants’ behavior. Clinical Trials may compare a new medical approach to a standard one that is …

The clinical study report described in this guideline is an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (referred to herein as drug or treatment) conducted …