This document outlines the organization of a clinical research department. It describes the major players in clinical research which include investigators, sponsors, ethics committees, contract research organizations, monitors, and regulatory authorities. It then provides details on the roles and responsibilities of investigators, sponsors, ethics committees, contract research organizations, monitors, and other key players. Finally, it discusses classification of clinical trials by purpose and type as well as electronic data capture systems used.

1. ORGANIZATION OF CLINICAL RESEARCH
DEPARTMENT
Dr. Jayesh Warade

2. CLINICAL RESEARCH
 Clinical trials are experiments done in clinical
research.
 Studying biomedical or behavioral research
studies on human participants

3. CLASSIFICATION OF CLINICAL TRIALS
 In a clinical observational studies, the
investigators observe the subjects and measure
their outcomes. The researchers do not actively
manage the study.
 In an interventional study, the investigators
give the research subjects a particular medicine
or other intervention. Usually, they compare the
treated subjects to subjects who receive no
treatment or standard treatment. Then the
researchers measure how the subjects' health
changes.

4. CLASSIFICATION TRIALS IS BY THEIR PURPOSE
 Prevention trials look for better ways to prevent disease
 Screening trials test the best way to detect certain
diseases or health conditions.
 Diagnostic trials are conducted to find better tests or
procedures for diagnosing a particular disease or
condition.
 Treatment trials test experimental treatments, new
combinations of drugs, or new approaches to surgery or
radiation therapy.
 Quality of life trials (supportive care trials) explore ways to
improve comfort and the quality of life for individuals with
a chronic illness.
 Compassionate use trials or expanded access trials

6. PLAYERS IN CLINICAL RESEARCH
 Major Player
 Investigator
 Sponsor
 Ethics Committee
 Contract Research Organization (CRO)
 Monitor/ Clinical Research Associates (CRA)
Other Players
- Site Management Organization (SMO)
- Clinical Research Coordinator (CRC)
- Regulatory Authority (Eg US FDA etc)
- Auditor
- Data Manager
- Project Manager

7. INVESTIGATOR
 Qualification – Prescribed by MEDICAL COUNCIL OF INDIA
 Medical Care of the Study Subjects: Medical Care, Medical Decision and treatment related to
adverse events, Informing to Patients about trials, Informing to other physician treating the
patients .Monitoring and auditing of Records: Investigator/institution responsible
 for monitoring and auditing all records by ethics committee, sponsor, CRO,
regulatory body.
 Training and delegation of responsibilities, information about protocols and
SOPs.
 Communication with Ethics Committee: Investigator / Institution should ensure about acceptance
of ethics committee for
 protocol,
 written consent form,
 subject recruitment procedure,
 written/verbal information provided to subjects
Investigator should inform ethics committee, monitor and sponsor
 Hazards of Protocols
 Risk to Subjects
 Adverse Reactions
 Any new information
 Deaths

8. INVESTIGATOR
 Compliance with the Protocol:
 Investigator/ Institution must agree and sigh the protocol
 May implement deviation as required – to be submitted to
ethics committee
 Deviation to be documented and explained
 Investigational Product:
 Records for product delivery to site
 Use by each subjects
 Return to sponsor/disposal
 dates, quantities, batch/serial numbers, expiry dates
 Instruction for use
• Selection and Recruitment of Study subjects: Process of recruitment
may be newspaper advertisement. Confidential List to be maintained

9. INVESTIGATOR
 Obligation regarding Informed Consent:
 Records/Reports:
 Accuracy
 Completeness
 Legibility
 Timeliness
• Progress Report:
Should submit the written summaries
Termination and Final Report:

10. SPONSOR
 Responsible for selection of investigator/
Institution

11. ETHICS COMMITTEE
 Review of all ethical aspects

12. CONTRACT RESEARCH ORGANIZATION
 Pharmaceutical Research Services

13. MONITOR/ CLINICAL RESEARCH ASSOCIATE
 Link between sponsor and investigator

14. CLINICAL RESEARCH COORDINATOR
 Responsible for conducting clinical trials
using good clinical practice

15. BIOSTATISTICIAN
 Make statistical model to help sponsor, CRO,
investigator.

16. QUALITY ASSURANCE
 Standard Operating Procedure
 Clinical trial audit – Investigator Site
 Expected/ Unexpected Inspection
 Suspension/ Premature termination of Study
 Regulatory Documents
 Intellectual Property Rights

17. ORACLE CLINICAL AND ELECTRONIC DATA
CAPTURE
 Oracle Clinical:
 Fully web based internet architecture
• Electronic Data Capture:
Electronic capture of trial data
 Clinical Conductor CTMS
 Flex database platform
 OpenClinica
 Entrypoint i4