The Drugs Controller General of India (DCGI) has issued the draft Accreditation Standards and Application Format for accreditation of ethics committee, investigator and clinical trial site which was prepared by the Quality Council of India (QCI).
Earlier last year, an Expert Committee under the chairmanship of Prof Ranjit Roy Chaudhury was constituted by the Union health ministry to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. One of the recommendations of the committee was that clinical trial should be conducted only at accredited sites by accredited investigator with the oversight of accredited ethics committees.
The ministry while agreeing to the recommendation, decided to assign the job of accreditation to QCI.
As per the document, for the accreditation of ethics committee, the list of applicable policies and procedures include: Composition, procedures for new induction and resignation of members; Frequency of ethics committee meetings; Receipt, review and decision making of proposals; Review of protocol amendments; Procedure for deliberations and maintaining minutes; Periodic review and oversight; Procedure to be followed for vulnerable population; Review of Informed Consent Document (subject information sheet and informed consent form) and informed consent process; Reporting, analysis of SAEs and making opinion on compensation; Handling issues related to non-compliances, protocol violation, complaints by the participants and other stakeholders; Declaration of conflict of interest and confidentiality agreement; Financial declaration of payments received and disbursed; Training for committee members; Communication with different stakeholders; Control and archiving of records; and SOP on SOP.
For the accreditation of investigator, the list of applicable policies and procedures include Investigator roles and responsibilities; and Investigator education, qualification and experience. Investigator will follow site SOPs and Study Protocol for all essential trial activities. If there is a contradiction, the study protocol requirement will be followed. Investigator will follow procedures but not limited to on informed consent, safety reporting and management, delegation of responsibilities and training, investigational product, protocol compliance and protocol deviations, clinical trial documentation, records retention and archival and destruction.
The list of applicable policies and procedure for the accreditation of clinical trial site include Subject protection policy (including transparent mechanism of enrollment and continuity of care of subjects in clinical trials); Informed consent, including procedures for audio-visual recording of consent; Medical management of adverse events; Adverse events and serious adverse events reporting (including emergency care) and compensation for trial injury; Roles and responsibilities of study team; Site research team training; Research pharmacy (investigational product management); Protocol compliance and protocol deviations; Documentation policy; Storage and retention of trial related documents; Conflict of interest disclosure policy; Resources (access to adequate laboratory facilities, adequate space and required medical and paramedical personnel, adequate arrangement for volunteers, subjects for isolation, recreation, food as applicable); Equipment calibration and maintenance; Quality management plan (including quality control measures); and Oversight by Ethics Committee.
The DCGI has invited suggestions and comments on these draft documents from the stakeholders within 30 days.