Home  >  Good Clinical Practices
 Premier Research India
you can get e-magazine links on WhatsApp. Click here
Good Clinical Practices
+ Font Resize -

Investigator should maintain essential documents

Wednesday, March 4, 2020, 08:00 Hrs  [IST]

Can a new investigational device use in phase I multi centric sponsored clinical trial?  

Dr Sreevatsa  

There is no concept of Phase I, II, III for medical devices.
As per Medical Device Rules 2017, the sponsor should perform pilot clinical investigation and/or pivotal clinical investigation before marketing the device in India.

Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific essential information about a device before beginning the pivotal clinical investigation. Pilot clinical investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition being studied before moving to large population and scope that give insight into the performance and safety of a device but cannot provide definitive support for specific mechanistic or therapeutic claims.

The pivotal clinical investigation is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use. Pivotal clinical investigation is confirmatory study that may be conducted in large number of patients with disease or condition being studied and scope to provide the effectiveness and adverse effects.

The sponsor should obtain regulatory approval for clinical investigation of medical device which includes: For investigational medical device developed in India, clinical investigation is required to be carried out in India right from pilot clinical investigation or first in human study and data generated should be submitted; For investigational medical devices developed and studied in country other than India, Pilot clinical investigation or relevant clinical study data should be submitted along with the application. After submission of such data generated outside India to the CLA, permission may be granted to repeat pilot study or to conduct pivotal clinical investigation. Pivotal clinical investigation is required to be conducted in India before permission to market the medical device in India except investigational medical device classified under class A, in exceptional cases, the CLA, may, for reasons to be recorded in writing, if consider it necessary, mandate conduct of clinical investigation, depending on the nature of the medical device.

If we look into compensation and medical management clause as per new rules then there is discrepancy regarding inclusion of these words “as per opinion of investigator”. Rule 40 includes these words. But, Table 3 – Informed consent document (ICD) point (ix) doesn’t include these words. Should we add these words in the ICD?
Neelu Singh

In New Drug Rules 2019 second schedule stipulates that application for permission to initiate specific phase of clinical trial should accompany trial subject's informed consent document as per Table 3 of Third Schedule. So, one cannot add any additional language to the ICD.
Rule 40 is relevant for the sponsor, investigator and EC. If the words from Rule 40 “as per opinion of investigator” are added the ICD, the patient may get confused about medical management. The language of point (ix)(a) assures the patient that she will get free medical management, irrespective of how/who made the decision to give free medical management.

Can an investigator request sponsor to archive essential documents?
Nina Sant

ICH GCP and Indian GCP require that the investigator should maintain the essential documents and should have control over these documents. So, the investigator can not request the sponsor to archive the essential documents.

See relevant excerpt: ICH GCP E6 R2 mandates:
The investigator/institution should maintain the trial documents as specified in essential documents for the conduct of a clinical trial and as required by the applicable regulatory requirement(s). The investigator/institution should take measures to prevent accidental or premature destruction of these documents.

The sponsor should obtain the investigator's/institution's agreement to retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data.

The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Indian GCP 3.3.8 stipulates that the investigator should maintain documents as specified in the essential documents’ list and take measures to prevent accidental or premature destruction.

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


Post Your commentsPOST YOUR COMMENT
* Name :     
* Email :    
  Website :  
Copyright © 2016 Saffron Media Pvt. Ltd |