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EC should consider unapproved proposals as new proposals and review thoroughly

Dr Arun Bhatt
Wednesday, August 2, 2023, 08:00 Hrs  [IST]

Ethics Committee (EC) has received a proposal to approve a clinical trial on medical device. The sponsor is of the opinion that the trial is an investigator initiated trial and therefore there is no need to get approval from the regulators to import and use the device in India. Is this acceptable?
Dr Sreevatsa

The EC should assess the purpose of this investigator initiated trial – academic or commercial.

Academic trial should comply with the provisions of New Drugs and Clinical Trials Rules (NDCTR) 2019. 

As per NDCTR 19, Investigator Initiated Trial is Academic Clinical Trial.
28 Academic clinical trial.

(1) No permission for conducting an academic clinical trial shall be required for any drug from the Central Licencing Authority where,
(i) the clinical trial in respect of the permitted drug formulation is intended solely for academic research purposes for a new indication or new route of administration or new dose or new dosage form; and
(ii) the clinical trial referred to in clause (i) has been initiated after prior approval by the Ethics Committee for clinical trial; and
(iii) the observations generated from such clinical trial are not required to be submitted to the Central
Licencing Authority; and
(iv) the observations of such clinical trial are not used for promotional purposes.
(2) In the event of a possible overlap between the academic clinical trial and clinical trial or a doubt on the nature of study, the Ethics Committee concerned shall inform the Central Licencing Authority in writing indicating its views within thirty working days from the receipt of application to that effect.

If the purpose of Investigator Initiated Trial is academic, the legal contract between the sponsor and the investigator should specifically include relevant legal statements.

If the sponsor plans to use the results of this investigator initiated trial, to support any commercial activity, then the trial should not be considered an academic trial. 

If the EC is not sure about regulatory status of such a trial, it can write to DCGI office for clarification.

What is regulatory expectation of a validated process for making a certified copy of clinical trial document?
Priyanka Wadhwa

Regulatory agency would expect to see certification when making copies of paper or electronic documents. The concept of "certified" copies means is that a copy of the original record can be relied upon to meet regulatory obligations in the same manner as the original record provided the copying process has been "verified" as producing a copy that contains all the attributes and meaning of the original document.

A photocopy of the original document should be verified through a validated process (such as visually by comparing information that's present on the original document with the photocopy) that the photocopying process captured all the attributes e.g., ink colour, stamped information, and content of the original record on the photocopy itself. Such a verified certified photocopy would meet regulatory requirements.
Certified paper copies of electronic documents, as per ICH E6(R2), should be generated through a validated process or verified (e.g., by a dated signature) as an exact copy having same attributes and information of the original documents, including any associated metadata (e.g., units of the data, date and time stamps, data originator, and other audit trail information associated with the data). If screenshots or paper printouts of an Electronic Medical Record are used to serve as a paper record and that record fails to capture important metadata and audit trail information that are recorded in the electronic system, such paper records would be regarded as incomplete unless the accompanying metadata and audit trail information are included. Regulatory inspectors would require access to the electronic system used to produce those data to review the complete record.

EC has received proposals submitted 2-3 years ago, which were not approved. These proposals are resubmitted.  How should EC review such proposals?
Dr Sreevatsa

EC should review all proposals not approved 2-3 years ago as fresh proposals. All submitted documents – protocol, ICF, supporting documents – should have been updated as per current scientific, regulatory, and ethical requirements. Hence, the EC should consider such unapproved proposals as new proposals, and review these thoroughly as per current scientific, regulatory, and ethical requirements.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com


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