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It is mandatory to notify CDSCO about protocol deviations

Wednesday, June 1, 2022, 08:00 Hrs  [IST]

Are medical devices included in Indian regulations?
Dr Ravi Vaswani
Medical devices were regulated under Medical Devices Rules, 2016. Recently, as per Gazette notification S.O. 648(E), the following devices intended for use in human beings or animals are considered as drugs with effect from the 1st day of April 2020.

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of -
(i) diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder.
(ii) diagnosis, monitoring, treatment, alleviation, or assistance for, any injury or disability.
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process.
(iv) supporting or sustaining life.
(v) disinfection of medical devices.
(vi) control of conception.
Medical devices are now governed by New Drugs and Clinical Trials Rules 2019 and Medical Devices Rules, 2016.

Is it necessary to notify CDSCO about protocol deviations?
Chandrika Asrani
Yes, it is mandatory to notify and obtain approval of ethics committee and CDSCO before implementing protocol deviations.

As per New Drugs and Clinical Trials Rules 2019 (vi) No deviations from or changes to the protocol should be implemented without prior written approval of the ethics committee and Central Licencing Authority except when it is necessary to eliminate immediate hazards to the trial subject or when change involves only logistic or administrative or minor aspects of the trial. All such exceptions must be immediately notified to the ethics committee as well as to the Central Licencing Authority. Administrative or logistic changes or minor amendments in the protocol should be notified to the Central Licencing Authority within thirty days.

This is also reinforced in Undertaking by The Investigator. See below clause: (ii) I agree to conduct the study in accordance with the current protocol. I will not implement any deviation from or changes of the protocol without agreement by the Sponsor and prior review and documented approval or favourable opinion from the ethics committee of the amendment, except where necessary to eliminate an immediate hazard to the trial subject or when the changes involved are only logistical or administrative in nature.

What are ethical considerations for Real World Studies (RWS)?
Dr Deepak Chaudhury
For retrospective RWS, EC approval is required. If approval not required, the investigator should obtain a waiver. If the data are acquired kept anonymized, informed consent may not be required. However, the investigator should submit the protocol for EC review and obtain waiver for informed consent.
For prospective RWS, EC approval and informed consent are essential. If the investigator plan to avoid taking consent, he/she should obtain a waiver from the EC.
Waiver of informed consent may be acceptable in the following situations
•    Research involves no more than minimal risk to the subjects
•    Waiver not adversely affecting the rights and welfare of the subjects
•    Research cannot practically be carried out without the waiver and the waiver is scientifically justified
•    Retrospective studies, where the participants are de-identified or cannot be contacted;
•    Research on anonymized biological samples/data
Research on data available in the public domain.


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Hasmukh Jul 20, 2022 7:40 AM
After completion of BA/BE study, follow-up of study participants is required to be done by investigator or as an alternative volunteer can be asked to communicate investigator for any health issue if found during washout period and investigator need not to take follow-up?
India Lab Expo
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