Question

Research a website that contains a Clinical trial protocol and read through the protocol and choose the parameters which you feel need to be closely followed throughout the trial. Think of the outcomes measures that would be required for safety and efficacy. Write a list (no more than a page) of these.

Please type, no plagiarism and give reference of the protocol.

Thanks

Answer 1

The protocol demonstrates guidelines for conduction of a clinical trial and explaining each essential part of it and how it is carried out. It is also describes the eligibility of participants,length of the study, the medication and the related tests. The parameters essential for conducting a clinical trials are 1.Protection of trial subjects (declaration, Ethics Committee, informed consent, confidentiality) 2.Medical care of the trial subjects, selection, compliance with the protocol, investigational product, trial site, serious ADR's, monitoring, auditing, record keeping, case report forms 3.Monitoring of safety ( handling and recording adverse events and reporting) 4.Record keeping and handling data 5.statistics and calculations 6.Handling and accountability of pharmaceutical products(supply and storage, labelling and package) 7.Role of the drug regulatory authority (on site inspection) 8.Quality assurance for conducting a clinical trial.

Reference:https://apps.who.int › pdfPDF
Web results
Guidelines for good clinical practice (GCP) for trials - World Health Organization