What are major changes in ICH GCP guidelines?

ICH GCP was amended in 2016. There are major changes in the following sections.

• Introduction
• Glossary
• GCP principles
• Investigator responsibilities
• Sponsor responsibilities
• Essential Documents/ (e)TMF

There are significant changes to improve quality and compliance to ensure human protection and data integrity.

These include

• Quality management system
• Risk based monitoring – centralized and on-site monitoring
• Electronic trial data – systems/SOPs, Validation of computerized systems  
• Significant noncompliance - root cause analysis and implementation of appropriate corrective and preventive actions.
• Essential Documents/ (e)TMF - control with the investigator  
• Source documents/data – Attributable, Legible, Contemporaneous, Original, Accurate, Complete

These changes will have significant impact on clinical trial conduct.

In a sponsored trial, PI wants to add one more visit of the patient to hospital in between already approved visits to observe the efficacy of the trial drug. This additional visit of patient requires DCGI approval? or notification to EC is enough?

As per CDSCO Checklist for new drugs, this change will come under category of Major Protocol Amendment. (See below)

Classification for major protocol amendment

• Amendment with respect to age limit of subject, dose, and treatment duration.
• Increase in number of subjects
• Amendment in study design
• Amendment in inclusion or exclusion criteria
• Amendment in safety or efficacy parameters
• Any other changes which has impact on safety of the subject

This study amendment will require approval from CDSCO.
The documentation for this approval includes:

• Covering letter
• Copy of CT permission letter
• Copy of previous protocol amendment approval letter, if any
• Copy of the amended protocol
• Changes made in comparison with earlier protocol to be presented with rationale and major changes should be highlighted
• Safety and efficacy data in support of proposed amendment
• Regulatory approval from participating key country/countries (in case of language other than English, English Translated version along with Translation Certificate)

I am a graduate student studying the effectiveness of a behavioral therapy on sleep, do I need DCGI permission to register my trial?

Your study on behavioral therapy does not require DCGI approval as it does not aim to study effect of a new drug.

CTRI registration is mandatory for clinical trials approved by DCGI office for new drugs. However, CTRI registration is voluntary for other non-interventional academic studies which do not have any commercial objectives e.g. support marketing of a new drug.

It would be desirable to register your study in CTRI, if you wish to publish your study, as most journals accept only studies registered in a registry e.g. CTRI for considering the study for publication.

I am engaged in development and evaluation of herbal formulations. We are planning to carry out clinical study on patients from our Ayurvedic hospital. Our prepared formulations are as per Ayurvedic classical texts only so do I need to take ethical committee permission to carry out Human clinical trials?

In 2010, Department of Ayurveda, Unani, Siddha, and Homeopathy (Ayush). introduced Rule 158(B) which made requirement of proof of effectiveness for licensing of patent or proprietary ASU medicine. Dept. of Ayush released GCP guidelines for voluntary use by the researchers interested in taking up clinical trials by using ASU medicine.

The investigators who wish to study Ayush drugs should follow Ayush GCP guidelines. So, it would be desirable to take ethics committee approval for your clinical trial project and register the study in Clinical Trial Registry of India.  This would be essential if you plan to publish your study, as many journals require that submitted article should have 1) EC approval and 2) should have been registered in Clinical Trial Registry.