Investigator Qualifications

The Indian GCP (3.3.1) insists that the investigator should be qualified as per the requirement of the Medical Council of Indian (MCI).This means that non-medical scientists e.g. pharmacists who organize the bio-equivalence studies, cannot become investigators.The qualifications of some of the senior investigators were not recognized as the medical institute from where these investigators were not approved by MCI at that time. Even in the medical field, several eminent investigators have medical degrees from UK or US, which are not prescribed by MCI.

Challenges- Investigator Qualifications
Implementation of this provision will require the monitors and auditors to ask the investigators for proof that their qualifications are in line with MCI.This provision can become a major hurdle for sponsors in selecting investigators and needs to be modified in line with ICH-GCP

Investigator and Sponsor’s SOPs
The Indian guideline (3.1.3) mandates that the sponsor and the Investigator should sign a copy of the Standard Operating Procedures (SOPs).Besides, the investigator and his staff have to be aware and comply with SOP.ICH-GCP expects the investigator to comply with the protocol and leaves the task of monitoring compliance to SOPs to monitors and auditors.

Challenges-Investigator and Sponsor’s SOPs
This provision is practically impossible, as the sponsor will have to obtain signatures of all investigators in a trial on its large number of SOPs. Imagine the task of making multiple copies of hundreds of Sops, delivering them to investigators, and obtaining their signatures! Besides, SOPs also get revised periodically and the whole cycles have to be repeated.

Investigators Responsibility for Data Analysis
Usually data analysis is the function of the sponsor. However, this provision makes it a responsibility of the investigator, increasing his burden. The CRFs are never sent to IEC unless the IEC asks for them for some specific purpose

Challenges-Investigators Responsibility for data Analysis
The IECs of major institute, which are involved in several international trials, are already struggling to cope with large number of bulky documents submitted for their approval. This provision will increase IECs’ trouble, as they have to create space for bulky CRFs and the clinical trial reports.

Monitors’ Qualifications
Indian GCP guidelines (3.2) suggest that the monitor should have adequate medical, pharmaceutical and/or scientific experience.

Challenges-Monitors’ qualifications
As most monitors are pharmacists or scientific graduates, they would not have adequate medical experience and hence will not qualify as monitors.

Schedule Y
Schedule Y refers to requirement and guidelines to be followed in order to attain permission of importing and/or manufacturing New Drugs to market or to undertake clinical trials in India.

Challenges in Conducting Good Clinical Practices
-Inadequate and inaccurate records
-Failure to conduct the study according to the protocol
-Problems with informed consent
-Timely and accurate reporting of adverse events
-Failure to follow the approved protocol
-Resistance to Government regulation of clinical trials
-Ethical considerations.