Registration of Clinical Research Organization

Definition: ‘Clinical Research Organisation’ means any commercial or academic or any other category of body owned
by an individual or an organization having the status of a legal entity by whatever name called, which is engaged
in conducting clinical trials; Assign or transfer related functions, duties and/or commitments, provided that
contractual transfers or commitments are to be transferred or assigned in writing.

Application for registration of clinical research organisation

1. Application for registration of Clinical Research Organisation for the purpose of conducting clinical trial or bioavailability or bioequivalence study with the Central Licencing Authority shall be made to the said authority in Form CT-07B.
2. Provided that the bioavailability/bioequivalence study centers already registered under rule 44 of these rules shall be permitted to conduct bioavailability/bioequivalence studies as defined under rule 2(1)(i) and the laboratories registered under rule 38A of these rules. Will be treated as a research organization and are not required to make any application under this rule for bioavailability/bioequivalence studies.

Grant of registration to scientific research organisation

1. Central Licensing Authority shall, after examining the information and documents furnished along with the
   application in Form CT-07B and making such further enquiries, if any, as it may consider necessary and being
   satisfied that that the requirements of these rules have been satisfied, grant registration to the applicant within fortyfive
   working days from the date of receipt of his application in Form CT-07B or failing which, under sub-rule (1) of rule
   38B ) reject the application for reasons to be recorded in writing within forty-five days from the date of making the
   application.
2. If the Central Licensing Authority considers that certain deficiencies in the application are serious and require to be corrected, that authority shall inform the applicant of the deficiencies within the period provided in sub-rule (1);
3. Where the applicant rectifies the deficiency within the period specified in clause (i) and provides the necessary information and documents, the Central Licensing Authority shall examine the application carefully and, if satisfied, grant registration to the applicant in Form CT-07C or If not satisfied, reject the application within a period of ninety days from the day the necessary information and documents are provided:
4. Provided that in case of rejection, the applicant may apply to the Central Licensing Authority for reconsideration of the application within a period of sixty days from the date of rejection of the application on payment of fee as specified in the Sixth Schedule and submission of necessary information and documents

Validity period and renewal of registration of clinical research organisation

1. A registration granted under rule 38C in Form CT-07C shall be valid for a period of five years from the date of
   its issue unless suspended or canceled by the Central Licensing Authority.
2. A scientific research organization shall, before the date of issue of its registration, make an application for renewal of registration in Form CT-07B along with the documents specified in the Ninth Schedule: