What authorizations and compliance should a clinical data management and Analytics Company is required to undertake?

Whether it is laboratory services, clinical research or any other facet or practice that forms the part of the process of diagnosis of diseases, their treatment, observe and examine the response of the disease to the treatment prescribed, disease surveillance, clinical research, data management or statistical analysis in this field, it requires an exceptional amount of quality control in order to ensure absolute certainty of the results. In fact, clinical data management and statistical analysis are the keys to uncovering new diseases and finding treatments for them. In order to maintain high standards in terms of quality, a code called the Good Clinical Practices (“GCP”) regulates all aspects of this function from designing, collecting, recording, maintaining all the clinical data. This blogs talks about the authorizations and compliances should a clinical data management and Analytics Company is required to undertake.

Factors affecting the quality of data stored:

Various considerations and factors that immensely influence the quality of clinical data collected have been discussed below:

  • Case Report Form (CRF): The CRFs should be systematically and meticulously drawn in order to ensure that the data collected is complete in all aspects and also precise. Further, the CRF and the protocol drawn for a particular project should also be coherent and any inconsistencies between the two must be avoided.
  • Field monitoring guidelines: These guidelines should be carefully drafted so as to ensure that they completely fulfill their purpose as the quality of these guidelines and their effective implementation will directly affect the quality of the data that is presented to the clinical data management system.
  • Source Data Verification: This is a very key step in the process of validating the data to ascertain the authenticity of the data that has been presented in terms of its integrity and accuracy.
  • Data conventions: This factor is relatively more relevant to the multicentre clinical trials. Usually, in these centers, the conventions that are followed are not uniform and hence, their varied nature acts as a hindrance to entering the data in the database and thereafter also maintaining it.

Enforcement of the laws related to drugs and cosmetics in India:

The Drugs and Cosmetics Act, 1940 (“the Act”) was enacted by the Central Government under the flagship of the Ministry of Health and Family Welfare to regulate all matters pertaining to import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act provides for standards of quality for all kinds of drugs being sold to the public- whether manufactured inside the country or imported, prohibition of drugs and cosmetics that may be adulterated or misbranded and also provides for the procedures that must be followed in obtaining registrations and compliances before circulating any kinds of drugs or cosmetics covered under the Act to the public.

More importantly, for the purpose of effective enforcement of the provisions of this law, the Act provides for setting up of the Drug Technical Advisory Board (“DTAB”). This body acts as an advisor to the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act. Being the highest technically constituted body under the Act, the DTAB recommended that the GCP guidelines must be followed for carrying out any activities related to clinical studies in India.

The Good Clinical Practices:

GCP is an ethical code on the level of quality that is to be maintained by the managers in these organizations. This code is one of the most integral and ancient codes that the practitioners of this field follow and was earlier called ‘the Hippocratic Oath’ based on the premise of causing no harm to the patient. Over time, with the development of medicine and need for induction of more modern and comparatively efficient methods, the antique code also required revisions in order to augment the efficiency of practitioners. Hence, the GCP. The Central Drugs Standard Control Organisation (“CDSCO”) of India, the national representative of the Government of India for all means and purposes regulates all matters related to drugs and cosmetics, set up to perform functions under the Drugs and Cosmetics Act, 1940 and the rules made thereunder. These guidelines were also formulated under the guidance of the CDSCO when this organization appointed an Expert Committee for this purpose.

This GCP is a set of guidelines for running tests, collecting the data and managing it with the fundamental objective of ensuring that the factors related to the research and the study undertaken related to the subject do not undermine the importance of human life being the subjects of these tests. Not only does this Code require that the study that is being done is scientifically sound but also ethically all-encompassing.

Compliance with international standards:

The GCP guidelines have been created and amended as and when required so as to keep then updated in line with the guidelines prescribed from time to time by World Health Organisation, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, United States Food and Drug Administration, the European GCP guidelines, and the ethical guidelines for biomedical research on human subjects issued by the Indian Council of Medical Research.

A brief summary of the provisions of the GCP guidelines:

The Code provides for provisions related to the audit of the data to avoid any source contradictions, quality assurance and quality control at the time of planning, conducting, monitoring, evaluating, data handling and reporting. In order to implement the same, it also provides for a mechanism for effectual data handling and management. It is provided therein that “A statement should be clearly made in the protocol that- The investigator(s) / institution(s) will permit study related monitoring, audits, ethics committee review and regulatory inspection(s) providing direct access to source data/documents and a copy of the CRF should be included in the protocol.  

Besides, the following details should be given:

  1. Procedures for handling and processing records of effects and adverse events to the product(s) under study
  2. Procedures for the keeping of patient lists and patient records for each individual taking part in the study.  Records should facilitate easy identification of the individual subjects. 

Conclusively, the GCP guidelines prescribe the practices that help in upholding the two cardinal principles of protecting the interests of the human subjects of the clinical research as well as warranting the reliability of the data and must be followed at all stages of data management, colleting, handling, maintaining etc.

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