3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

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58agreement by the Sponsor and prior review and documented approval /favorable opinion from the Ethics Committee of the amendment, except wherenecessary to eliminate an immediate hazard(s) to the trial Subjects or when thechange(s) involved are only logistical or administrative in nature.(iii) I agree to personally conduct and/or supervise the clinical trial at my site.(iv) I agree to inform all Subjects, that the drugs are being used forinvestigational purposes and I will ensure that the requirements relating toobtaining informed consent and ethics committee review and approvalspecified in the GCP guidelines are met.(v) I agree to report to the Sponsor all adverse experiences that occur in thecourse of the investigation(s) in accordance with the regulatory and GCPguidelines.(vi) I have read and understood the information in the Investigator's brochure,including the potential risks and side effects of the drug.(vii) I agree to ensure that all associates, colleagues and employees assisting inthe conduct of the study are suitably qualified and experienced and they havebeen informed about their obligations in meeting their commitments in thetrial.(viii) I agree to maintain adequate and accurate records and to make thoserecords available for audit / inspection by the Sponsor, Ethics Committee,Licensing Authority or their authorized representatives, in accordance withregulatory and GCP provisions. I will fully cooperate with any study relatedaudit conducted by regulatory officials or authorized representatives of theSponsor.
59(ix) I agree to promptly report to the Ethics Committee all changes in theclinical trial activities and all unanticipated problems involving risks to humanSubjects or others.(x) I agree to inform all unexpected serious adverse events to the Sponsor aswell as the Ethics Committee within seven days of their occurance.(xi) I will maintain confidentiality of the identification of all participatingstudy patients and assure security and confidentiality of study data.(xii) I agree to comply with all other requirements, guidelines and statutoryobligations as applicable to clinical Investigators participating in clinical trials8. Signature of Investigator with Date
Page 4 and 5:
42. CLINICAL TRIAL(1) Approval for
Page 7 and 8: 7(5) Responsibilities of the Ethics
Page 9 and 10: 9study and to determine the common
Page 11 and 12: 11(1) Geriatrics.-Geriatric patient
Page 13 and 14: 13(viii)For clinical trials conduct
Page 15 and 16: 15(ii) Evaluation of the effect of
Page 17 and 18: 172.6. 2.6. Stability Studies (for
Page 19 and 20: 198.2. 8.2. Bio-availability / Bio-
Page 21 and 22: 21brief description of the trial de
Page 23 and 24: 2315. List of References16. Appendi
Page 25 and 26: 25whichever is higher) is recommend
Page 27 and 28: 27hours. Animals should be observed
Page 29 and 30: 29showing minimal toxicity in syste
Page 31 and 32: 31One male and one female from each
Page 33 and 34: 33taken. Formulation in volume comp
Page 35 and 36: 35the same route in a batch of 4 ma
Page 37 and 38: 37(i) (i) In-vitro exposure (with a
Page 39 and 40: 39At least three dose levels should
Page 41 and 42: 41Female Reproduction and Developme
Page 43 and 44: 43Reaction(pH)• • Bilepigments
Page 45 and 46: 45Allergenicity/Hypersensitivity te
Page 47 and 48: 47Specific and general pharmacologi
Page 49 and 50: 49These include ventricular contrac
Page 51 and 52: 511.6 Application Of Good Laborator
Page 53 and 54: 5313. Statement that participation
Page 55 and 56: 55Signatory’s Name: _____________
Page 57: 57Appendix VIIUNDERTAKING BY THE IN
Page 61 and 62: 612. Format for Approval of Ethics
Page 63 and 64: 63Appendix IXSTABILITY TESTING OF N
Page 65 and 66: 65(i) Study conditions for drug sub
Page 67 and 68: 67Previous clinical work with the n
Page 69 and 70: 69d. Possible drug interactionse. C
Page 71 and 72: 71Appendix XIData Elements for repo
Page 73: 73(F.No. X-11014/1/2003-DMS & PFA)(
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3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

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