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), Indian GCP
guidelines & ICH guidelines mandate that ,
sponsor only use trained and qualified
investigators.

3. A. 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:
1. Providing initial training on adverse event reporting
requirements for investigators
2. Reviewing data to assure accuracy and completeness
of reported events.
3. Providing new information to the investihgator
4. Monitoring the clinical trial to detect potentially
unreported adverse events
5. 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. 1. Investigational site audits
2. Clinical department, process
audits
3. Data management audits
4. Safety department audits
5. GCP laboratory audits
6. 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
1. Review clinical trial of both registered and non registered medical
substances
2. Ensure that drug available fulfils the necessary requirements for safety,
quality and efficacy.
3. Should terminate any ongoing trial if there are serious breaches or
malpractices of GCP
4. Implement a regulatory system to register, to conduct all clinical trials
5. Promote, ensure and monitor compliance by approved ethics committee
6. Effectively review all documents before giving permission for the
marketing of a new drug