Clinical research organisation (CRO) [5: A CRO is an organisation to which the sponsor may transfer or delegate some or all of the tasks, duties and/ or obligations regarding a Clinical Study.  All such contractual transfers of obligations should be defined in writing.

Schedule “Y” is gives requirements and guidelines for permission to import and /or manufacture of new drugs for sale or to undertake clinical trials.

Sponsor: It is an individual/ company, institution or organization which takes responsibility for the initiation, management, and financing of clinical trials.

A] Responsibilities of Sponsor:

a) The clinical trial Sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and Good Clinical Practice (GCP). Guidelines issued by the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India as well as with all applicable statutory provisions.  Standard operating procedures should be documented to ensure compliance with GCP and applicable regulations.
b) Sponsors are required to submit a status report on the clinical trial to the Licensing Authority at the prescribed periodicity.
c) In case of studies prematurely discontinued for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months.  The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any, and the reason for discontinuation of the study or non-pursuit of the new drug application.
d) If any unexpected serious adverse event (SAE) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study.

 B] Investigator and Institution Selection:The Sponsor is responsible for selecting the Investigator(s) / Institutions taking into account the appropriateness and availability of the study site and facilities.  The Sponsor must assure itself of the Investigator’s qualifications and availability for the entire duration of the Study.  If organisation of a co-ordinating committee and or selection of co-ordinating investigators are to be utilised in multi-centric studies their organisation and / or selection are Sponsor’s responsibilities.

C] Contract: The Sponsor should enter into a formal and legal agreement / contract with the Investigator(s) / Institution(s) on the following terms:

· To conduct the Study in compliance with GCP, the applicable regulatory requirements and the Protocol agreed to by the Sponsor and given approval / favourable opinion by the Ethics Committee.

· To comply with the procedures for data recording, and reporting.

· To permit monitoring, auditing and inspection.

· To retain the study related essential documents until the Sponsor informs the Investigator(s) / Institution(s) in writing that these documents are no longer needed.

· The agreement should define the relationship between the investigator and the sponsor in matters such as financial support, and payments in kind etc.

The Sponsor should establish detailed Standard Operating Procedures (SOP’s).  The Sponsor and the Investigator(s) should   sign a copy of the Protocol and the SOPs or an alternative document to confirm their agreement.

Compensation to Subject and Investigators:

  1. If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.
  2. The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s).

Investigators: It is a person who is responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority.

  1. The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.
  2. The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
  3. The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority (is).
  4. The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

Investigational Product: It is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packed) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about the approved use.