Roles and responsibilities of investigator

Investigator roles

1. SPONSOR- individual, company , institution or organization, which takes responsibility for the initiation, management and or financing of a clinical trial. ROLES & RESPONSIBILITIES Selection of investigator and institution/hospital Contract/agreements Compensation to subjects Information on investigational products Supply &handling of investigational products Safety information ADR reporting Record acess Monitoring Audt Premature termonation or suspension of trial Manufacturing, packaging. Labeling and coding of investigational products Multicenter trials

2. INVESTIGATOR A person responsible for the conduct of the clinical trial at a trial site. If the trial is conducted by a team of individual at the trial site, the investigator is the leader of the team called as principal investigator. Roles & Responsibilities FDA regulations(21CFR 312.52), I ndian GCP guidelines & ICH guidelines mandate that , sponsor only use trained and qualified investigators.

3. Initiating a clinical trial contracts and agreements obtaining ERB/IRB approval to conduct the trial constituting a study team planning & ensuring resource s required for conduct of trial attend the trial training meeting along with the study team B. conduct of the trial Recruitment of subjects in the study informed consent document administration medical care of trial subject communication with IRB/IEC communication with sponsor documenting errors, violations, non complianc etc.. Financial tracking ensuring confedentiality C site closure Final report to IRB/IEC Providing all data/documents required at site closure to sponsor return of euipment , investigational prouduct & grnts reconcilation archival of trial data for the duration as soon as a specified in the contract premature termination or suspension of a trial.

4. CLINICAL RESEARCH ASSOCIATE CRA is a health care professional who performs many activities related to medical research particularly clinical trials employed by a conuct research organization which works on behalf of pharmaceutical companies.

5. ROLES & RESPONSIBILITIES There are five major areas of responsibility through which the CRA can impact knowledge of adverse event reporting to investigators: Providing initial training on adverse event reporting requirements for investigators Reviewing data to assure accuracy and completeness of reported events. Providing new information to the investihgator Monitoring the clinical trial to detect potentially unreported adverse events Assuring follow-up data is reported for adverse events when required.

6. Assesses site qualification potential Participate in the implementation of clinical studies Supervises the conduct of clinical studies Ensure the quality of the project Closes clinical studies Coordinates clinical trials Ensure quality assurance of projects

7. AUDITOR An independent individual appointed by sponsor or regulatory to conduct a systematic and in depth examination of trial conduct and compliance with protocol GCP standard operating procedures and applicable regulatory requirements.

8. Investigational site audits Clinical department, process audits Data management audits Safety department audits GCP laboratory audits Sponsor central file audits

9. CONTRACT RESEARCH CORDINATORS CRC’s are defined as a personnel employed at clinical investigator’s site to record the clinical trial data in compliance with protocol, GCP and applicable regulatory guidelines.

10. Before the start of the clinical trial Feasibility Proposal budget Institutional review board submissions DURING THE CONDUCT OF CLINICAL TRIAL Informed consent Conduct of research Adverse events After the close of the clinical trial

11. Regulatory authorities These are the bodies that power to regulate the clinical trials. Regulatory authorities review submitted clinical data and those that conduct inspections roles & responsibilities Review clinical trial of both registered and non registered medical substances Ensure that drug available fulfils the necessary requirements for safety, quality and efficacy. Should terminate any ongoing trial if there are serious breaches or malpractices of GCP Implement a regulatory system to register, to conduct all clinical trials Promote, ensure and monitor compliance by approved ethics committee Effectively review all documents before giving permission for the marketing of a new drug