An Investigator Site File (ISF) contains essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements set out by the ICH GCP guidelines.According to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, essen...
The principles outlined in the “Guideline for Good Clinical Practice” ICH Tripartite Guideline (January 1997) are considered the minimum standard for Roche clinical trials. The Good Clinical Practice (GCP) guidelines include standards on how clinical trials should be conducted and define the roles...
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines:This is a set of global guidelines for the development, registration, and post-approval of pharmaceuticals. Good Clinical Practice (GCP) guidelines:This is an international...
the EMA “Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials”, which notes in Section 3.1 that “The TMF is usually composed of a sponsor TMF, held by the sponsor organisation, a...
(Jain, SK. 2008). The International Conference on Harmonization Good Clinical Practice (ICH GCP) guideline ascertaines SOPs as “detailed, written instructions to achieve uniformity of the performance of a specific function”. SOPs must be well written in order to supply an efficacious control of...
Phase I trials are non-randomized studies designed to investigate the pharmacokinetics of a drug (i.e. how a drug is distributed and metabolized in the body) includ- ing finding a dose that can be tolerated with minimal toxicity. Phase II trials provide preliminary evidence on...
Prompt start-up, an experienced staff and strong recruitment and retention strategies are part of every trial we implement. Our tenured staff is educated on standard FDA requirements, respect for Volunteer’s Rights and ICH/GCP Guidelines. Each research study is carefully planned and conducted to ...
Clinical trials should always be conducted in accordance with the Declaration of Helsinki [111] and the guidelines for Good Clinical Practice (GCP) [112] to ensure ethical and scientific quality requirements are followed throughout the study design, conduct, recording of information, and reporting ...
The success of a clinical trial depends on recruiting and retaining an adequate number of representative patients to answer the question at hand, adherence to protocol during trial conduct, following good clinical practice (GCP) guidelines [2], and minimizing barriers to facilitate successful trial ...