Share this
clinical trials: 5 recent regulatory changes you should know about
by Neoteryx on May 15, 2019 5:15:00 AM
Regulations regarding clinical trials have recently changed. These changes are to ensure transparency of the process and increase credibility. Changes include:
1. Expansion of Registration/Training to All NHI-Defined Clinical Trials Under NHI Policies
This regulation involves training of defined clinical trials for 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 the NHI 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. NHI- and 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 FDA provides guidance for electronic data input, data format in Drug evaluation and research for a successful compiling of new drugs application. The NHI- and FDA-specific statement in the consent form assist 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 test 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 the clinical trials, the results must be submitted within 12 months. These results include the primary data gathered and in the tabulated format.
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, comply with all applicable regulations and best practices, and use the best and most modern tools and technologies available, you will be able to make your clinical trials run more smoothly.
Share this
- Venipuncture Alternative (106)
- Clinical Trials, Clinical Research (68)
- Mitra® Device (38)
- Research, Remote Research (32)
- Dried Blood Spot, DBS (31)
- Therapeutic Drug Monitoring, TDM (12)
- Blood Microsampling, Serology (10)
- Infectious Disease, Vaccines, COVID-19 (10)
- Decentralized Clinical Trial (DCT) (9)
- hemaPEN® Device (6)
- Pharmaceuticals, Drug Development (5)
- Toxicology, Doping, Drug/Alcohol Monitoring, PEth (5)
- Antibodies, MAbs (3)
- Harpera® Tool (3)
- Omics, Multi-Omics (3)
- Skin Microsampling, Microbiopsy (3)
- Biomonitoring, Health, Wellness (2)
- March 2023 (1)
- February 2023 (2)
- January 2023 (3)
- December 2022 (2)
- November 2022 (3)
- October 2022 (4)
- September 2022 (3)
- August 2022 (5)
- July 2022 (2)
- June 2022 (2)
- May 2022 (4)
- April 2022 (3)
- March 2022 (3)
- February 2022 (4)
- January 2022 (5)
- December 2021 (3)
- November 2021 (5)
- October 2021 (3)
- September 2021 (3)
- August 2021 (4)
- July 2021 (4)
- June 2021 (4)
- May 2021 (4)
- April 2021 (3)
- March 2021 (5)
- February 2021 (4)
- January 2021 (4)
- December 2020 (3)
- November 2020 (5)
- October 2020 (4)
- September 2020 (3)
- August 2020 (3)
- July 2020 (6)
- June 2020 (4)
- May 2020 (4)
- April 2020 (3)
- March 2020 (6)
- February 2020 (3)
- January 2020 (4)
- December 2019 (5)
- November 2019 (6)
- October 2019 (4)
- September 2019 (5)
- August 2019 (5)
- July 2019 (4)
- June 2019 (7)
- May 2019 (6)
- April 2019 (5)
- March 2019 (6)
- February 2019 (6)
- January 2019 (8)
- December 2018 (3)
- November 2018 (4)
- October 2018 (7)
- September 2018 (8)
- August 2018 (6)
- July 2018 (8)
- June 2018 (6)
- May 2018 (5)
- April 2018 (6)
- March 2018 (5)
- February 2018 (7)
- January 2018 (4)
- December 2017 (2)
- November 2017 (3)
- October 2017 (2)
- September 2017 (4)
- August 2017 (2)
- July 2017 (4)
- June 2017 (5)
- May 2017 (6)
- April 2017 (6)
- March 2017 (5)
- February 2017 (4)
- January 2017 (1)
- July 2016 (3)
- May 2016 (1)
- April 2016 (2)
No Comments Yet
Let us know what you think