- The CTEC will be responsible for evaluation and approval of the application, considering the reports submitted by reviewer.
- The CTEC may approve or may reject the application and specify the reasons for such rejection.
- If the trial is being approved by the CTEC the decision will be communicated to the applicants in writing, by the NMRA after obtaining the Ethical approval from respective ERC for the trial, by issuing the applicant a “Letter of Authorization”. The period of validity of such letter will be decided by the CTEC/CTRD based on the trial protocol and other relevant details.
- In case of rejection, the applicant may appeal and provide additional information where applicable and whenever required.
Approval
- Details