Regulations regarding clinical trials have recently changed. These changes are to ensure transparency of the process and increase credibility. Regulatory changes include:
1. Expansion of Registration & Training for Clinical Trials
This regulation involves training on Good Clinical Practices (GCP) that address the quality of clinical trials, safety measures, and integrity in terms of design and conduct. The training has additional conditions to meet requirements to protect human concerns.
You must retain documentation of the GCP training.
Training must be renewed every three years.
You are also to provide the training documentation upon completion.
2. FDA-Specific Statement on Clinical Trials
Duration in which participants are required to register before the start of the clinical trials
Deadline for submitting results upon the trial completion
In efforts to ensure seamless process data registration, the Food and Drug Administration (FDA) provides guidance for electronic data input, data format in drug evaluation, and research for a successful compiling of new drugs application. The FDA-specific statement in the consent form assists in conformance of the agreement and the requirements of clinical trials.
3. Period of Trial Registration After the First Group of Participants
Some clinical trials may require study subjects to be enrolled at different timeframes. According to the regulations, participants must register via the Protocol Registration System no later than 21 days after first applicant enrollment. Before enrollment in the applicable clinical trial, applicants must receive a consent document after the application process.
4. Period for Submitting Results
Upon completion of a clinical trial, the results must be submitted within 12 months. These results include the primary data gathered.
5. Potential Repercussions for Non-Compliance
The hazards of failing to comply with regulations are getting more severe. Breaching the codes of conduct and agreements can lead to suspension or even termination. This includes cases where there is no verification of the required registration and reporting of defined clinical trials.
However, if you take time to understand the regulatory environment around clinical trials (including remote or decentralized clinical trials), and comply with all applicable regulations and best practices, you will be able to make your clinical trials run more smoothly.
To learn about conducting hybrid, remote or decentralized clinical trials by utilizing remote microsampling devices and sample collection kits, visit our Decentralized Clinical Trials Resource Page via the link below: