Requirements for Filling Applications for Global Clinical Trial
(for submission of data to countries other than India also)

  1. Name of the Applicant
  2. Authorization letter from the Sponsor
  3. Name of the Drug
  4. Regulatory status of the drug in other countries (Names of countries where the drug is approved along with international package insert or where IND application is filed)
  5. Objective of the Study
  6. Phase of Study
  7. Names of  theParticipating Countries /Investigator sites
  8. Total no. of  patients to be enrolled globally
  9. No. of investigator sites to be enrolled in India
  10. No. of patients to be included in India
  11. Regulatory/ IRB approvals from participating countries
    (these approvals should be submitted along with their English translation and reason in case the company is submitting an expired IRB/ IEC approval)
  12. Status of the study in other countries(this should include no. of patients enrolled, no. patients completed the study and no. of  patients discontinued)
  13. Suspected Unexpected  Serious Adverse Reaction (SUSAR) from other participating countries if any reported
  14. Affidavit from the sponsor that the study has not been discontinued in any country and in case of discontinuation the reasons for such a discontinuation and that the applicant  would further communicate to DCG (I) about future discontinuation

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    September 9th, 2007|

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