• CATEGORY      A/B
  1. Name of the Company/ CRO
  2. Authorization letter from the Sponsor
  3. Name of the Drug
  4. Objective of the Study
  5. Phase of Study
  6. Names of Participating Countries Centers
  7. Total no. of  patients to be enrolled globally
  8. No. of centers to be included in India
  9. No. of patients to be included in India
  10. Regulatory/ IRB approvals from participating countries
  11. Status of the study in other countries
  12. Serious adverse event from other participating countries if reported
  13. Affidavit from the sponsor that the study has not been withdrawn from any country and in case of withdrawal of study the same would be communicated to the DCG (I) office at the earliest
  14. Data Submitted -Chemical and Pharmaceutical data
    • Generic name and chemical name
    • Dosage form
    • Composition
    • Animal Pharmacological Data
    • Animal Toxicology data
    • Clinical data 
    • Phase I
    • Phase II
    • Phase III
    • Phase IV
    • Rationale for selecting the proposed dose in the trial
    • 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)
  15. Documents Submitted
    • Form 44 and Treasury chalan
    • Form 12 and Treasury chalan
    • Details of Biological samples to be exported
    • Protocol and Informed consent form
    • Case Report form
    • Investigator’s Brochure duly supported by an affidavit that the summarized information submitted  is based on facts
    • Undertakings by the Investigators
    • Ethics committee approvals ( if any)

PROTOCOL AMMENDMENTS

A. Those amendments which do not require any information or permission

  • Administrative and Logistic changes
  • Minor protocol amendments and additional safety assessments  in case the institutional ethical committee has already approved these changes

B.Those amendments which require to be informed but need not wait for permission

  • Additional Investigator sites
  • Amended Investigators Brochure, amended informed consent

C.Those amendments which require prior permission before implementation of the amendments.

  • Change of Principal Investigator
  • Additional Patients to be recruited
  • Major changes in protocol with respect to study design, dose and treatment options