Requirements for Filling Applications for Global Clinical Trial
(for submission of data to countries other than India also)
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Name of the Applicant
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Authorization letter from the Sponsor
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Name of the Drug
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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)
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Objective of the Study
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Phase of Study
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Names of theParticipating Countries /Investigator sites
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Total no. of patients to be enrolled globally
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No. of investigator sites to be enrolled in India
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No. of patients to be included in India
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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) -
Status of the study in other countries(this should include no. of patients enrolled, no. patients completed the study and no. of patients discontinued)
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Suspected Unexpected Serious Adverse Reaction (SUSAR) from other participating countries if any reported
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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