Clinical research is necessary to establish the efficacy and safety of specific health products and medical practices. All the key changes, revisions and amendments in guidelines are designed to help clinical researchers and practitioners to protect human subjects and properly document trial results, maintain data quality and integrity. Good Clinical Practice (GCP) Guidelines Clinical research […]
Compliance with guidelines of Good Clinical Practice (GCP) as the minimum standard is identified as key characteristics for conducting clinical research. Clinical research is conducted in a manner to provide public assurance; safeguard rights, safety and wellbeing of involved participants and generate reliable data. The accessibility and accuracy of preserved records should be easily retrievable for […]
Good Clinical Research Practice (GCP) helps design, conduct and report clinical research in an ethical and scientific manner. Various training programs are commissioned to train a cadre of clinical researchers on using global standards tools and systems for developing and conducting clinical trials on public health products like vaccines, drugs, biologics, medical devices or healthcare […]
An update as an addendum to the ICH GCP E6 has been released by European Medicines Agency (EMA) for comments from the public.
The Supreme Court of India has acted upon the DCGI and has made it mandatory for all Multi National Companies and whoever wishes to conduct clinical trials in India to compulsorily video record the informed consent procedure in clinical trials.
A digital signature, also referred to as an electronic signature has been developed using the cryptographic techniques of verifying the originator. Using this technique, the identity of the person who uses a digital signature can be verified. The electronic system uses a complex set of rules and parameters to achieve this. A digital signature is also known […]
The Clinical Research Certificate Program is a far less exhausting course than a full time degree program as it is more or less directed towards professionals than students and fresher. The program is designed to target project managers, principal investigators, and faculty members, who look forward to abreast themselves to the latest in clinical research […]
Good Clinical Practice (GCP) is a well accepted global scientific quality and moral standard for performing clinical studies that engage human volunteers. ICH-GCP certification is mandatory for any professional who try to associate with clinical research anywhere around the Globe. This is making GCP training a compulsion to participate or carve a career in this […]
Good Clinical Practice (GCP) is a well accepted global scientific quality and moral standard for performing clinical studies that engage human volunteers. ICH-GCP certification is mandatory for any professional who try to associate with clinical research anywhere around the Globe. This is making GCP training a compulsion to participate or carve a career in this […]
GCP training and certification :- GCP / ICH-GCP is an international ethical and scientific standard or guiding principles to start, execute, collect and report clinical research outcomes that involve humans as study volunteers. The fulfillment of these principles guarantees end users that the human subjects’ rights, safety and wellbeing are protected according to the principles laid […]