Get Protocol Feasibility Process And Forms For ... - First Clinical Research

There are 3 main phases of clinical trials – phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.

In general terms, clinical trial feasibility is a process of evaluating the possibility of conducting a particular clinical program / trial in a particular geographical region with the overall objective of optimum project completion in terms of timelines, targets and cost.

Clinical research process Prepare project budget – review sponsor role and include monitoring in budget if required. Apply for and secure funding. Initiate contract discussions (if applicable) Obtain internal/departmental approval.

Step 1 – Identify a clinical problem or area of interest that you believe has research potential.

Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.

A feasibility questionnaire (FQ) is the set of questions prepared by a study sponsor or contract research organizations (CROs) to identify the potential and interest of a site/investigator to run clinical trial feasibility successfully.

Definition. A clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.

Clinical trials that get off to a good start are more likely to be successful trials. The study startup phase is where this happens, and includes such activities as; investigator selection, regulatory and ethics submissions, site training and ends with the site initiation visits.