http://www.gcphelpdesk.com - The newly designed GCP Help Desk tool is a free online resource that aims to provide valuable information in the field of Clinical Research. This tool is a ready reckoner of ICH GCP guidelines for clinical research professionals.
http://www.gcphelpdesk.com - This page gives more information about quality assurance and quality control according to ICH GCP guidelines like when should be the Audit certificate be issued and procedure to select sample number of case report forms (CRFs) for source data verification and more..
http://www.gcphelpdesk.com - GCP Help Desk is just a click away providing information on any of queries related gcp and other regulations.This page gives information about serious adverse events which includes time frame for SAE reporting, guidelines for collection of non-serious adverse events, and Reporting serious adverse events (SAE) to ethics committees etc.
http://www.gcphelpdesk.com - GCP Help desk provides information on clinical trails and there are some faq's which is focused on clinical trail Investigator and Investigator Site.
http://www.gcphelpdesk.com - The ICH Guideline on study reports, section 16.1.4 states that a 'list & description of investigators and other important participants in the study, including brief CV or equivalent summary of training includes other important participants are the people who are signed up as sub-investigators and have delegated tasks and study nurses should be included.
http://www.gcphelpdesk.com - Trial master file (TMF) is a file that contains all the essential documents relating to a clinical trial, before the trial commences during trial conduct and after the completion of trial.The consent forms are a confidential transaction between the investigator and the subject.
