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Green Plants

Clinical Trials & Research Institutions

Regulatory Requirements
& Compliances

With the growing advancements in medical research, the number of clinical trials and studies have increased exponentially. Each clinical trial comes with its own set of risks and potential liability for the entities involved. From minor complications, to unexpected outcome to a life-threatening result, clinical trials are a high-risk process with the potential for unlimited liability put on the organizing entity.

From idea generation to clinical trials, the process of clinical research and development has numerous mandated compliances, permissions, licenses and approvals. Non-compliance with even one of them can result in the clinical trial being shut down, suspended and even the entity being blacklisted. The Central Pharmaceuticals Standard Control Organization (CDSCO) is the primary organization in India responsible for creating the rules and regulations governing drugs, cosmetics, diagnostics, and devices.

Clinical trials must go through several checks and prerequisites to ensure complete compliance. This is applicable for everything from the clinical investigations to drug production and purchase to the marketing of the drugs in India. Apart from these there are various other regulations and compliances for a clinical trial in India. In order to make sure that you are fully compliant with these regulations you must consult an attorney.

Image by Microsoft 365

Budgeting & Billing Compliances

Sponsors and sites alike are forced to increase their expenditures as the clinical research sector carries out an increasing number of trials. Due to the growing demand for advancing the proposed drug or therapy into the market, they are forced to entertain and seek charges. Double billing, incorrectly judging clinical trials to be qualifying, falsely invoicing non-covered items/services as normal charges, etc., are a few major causes of billing compliance problems.

Knowing how to start becoming more compliant is essential now that we are aware of the causes of billing compliance mistakes. Asking questions like ‘are we in compliance with billing practices?’; ‘are these expenses sufficient?’; ‘Are there any expenses I'm overlooking?; ‘How quickly do I have to proceed with this trial?’. All these questions can be answered by consulting an attorney who can help you comply with all the budgeting and billing requirements.

Image by Austin Distel

Data Protection Compliance

As a clinical trial provider, you are a controller under the General Data Protection Regulations (GDPR) for the data of your employees, clients, and subcontractors as well as a processor in terms of patient data, with a sponsor serving as the controller. Clinical trial data, on the other hand, is regarded as a "special" data category with tougher restrictions on processing. Clinical trials at least have a justifiable reason for processing because processing medical data is required for scientific or research objectives.

The consequences for violating GDPR are severe. Companies outside of the European Union (EU) that supply services or products to EU citizens or otherwise keep track of their behavior are likewise affected by GDPR. It is necessary to make sure that the clinical trial is GDPR compliant in order to avoid any hefty penalties or fines.

Image by National Cancer Institute

Clinical Trial Agreements

One of the important legal documents that control how clinical trials are conducted is the Clinical Trial Agreement. It describes each party's duties and commitments for the clinical trial and serves as a formal contract between a pharmaceutical company and a Contract Research Organization. It is crucial that both the parties comprehend the significance of these agreements and how they are created, negotiated, and carried out.

The agreement details each party's roles and duties, the conduct of the study in accordance with Good Clinical Practices, any applicable legal or ethical requirements  and the authorized protocol, adherence to the guidelines for data collecting and reporting, the terms of confidentiality and non-disclosure, the specifics of insurance and indemnity, and such information as may be required. As a result, it's crucial to confirm that the agreement was prepared with the help and guidance of a knowledgeable and experienced lawyer in this area.


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