Study materials of GCPs and Various Ethics Guidelines

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Central Drugs Standard Control Organization

>> Guidance for Industry E6 Good Clinical Practice Consolidated Guidance
>> HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE
>> Good clinical practice guidelines
>> ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
>> WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
>> International Ethical Guidelines for Biomedical Research Involving Human Subjects
>> Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
>> DRUGS AND COSMETICS (IIND AMENDMENT) RULES, 2005
>> ACTIONS ON THE RECOMMENDATIONS OF PROF. RANJIT ROY CHAUDHURY EXPERT COMMITTEE TO FORMULATE POLICY AND GUIDELINES FOR APPROVAL OF NEW DRUGS, CLINICAL TRIALS AND BANNING OF DRUGS
>> The Belmont Report
>> The gazette of india extraordinary
>> Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Exception from Informed Consent Requirements for Emergency Research
>> COMPENSATION FORMULA
>> THE NUREMBERG CODE
>> Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
>> GUIDANCE ON CLINICAL TRIAL INSPECTION
>> Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research
>> Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees
>> The gazette of india
>> Clinical trials related websites/ links for softwares
>> Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
>> The gazette of india
>> Global Clinical Trial
>> Guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators
>> The gazette of india
>> FORM
>> DRAFT GUIDELINES ON AUDIO-VISUAL RECORDING OF INFORMED CONSENT PROCESS IN CLINICAL TRIAL
>> GUIDELINESON AUDIO-VISUAL RECORDING OF INFORMED CONSENT PROCESS IN CLINICAL TRIAL
>> GUIDELINESON AUDIO-VISUAL RECORDING OF INFORMED CONSENT PROCESS IN CLINICAL TRIAL
>> Guidelines for Bioavailability Bioequivalence Studies
>> 12_ANNEXURE_B7_Guidelines for BA, BE _CDSCO
>> DRAFT GUIDANCE FOR INDUSTRY ON REPORTING SERIOUS ADVERSE EVENTS OCCURING IN CLINICAL TRIALS
>> Office of Drugs Controller General (India) New Drugs Division