21 cfr 312.62 and 812.140

Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES.
at 21 CFR §312 and the FDA Investigational Device Exemption (IDE) provisions at 4 FDA 21 CFR (b) & 21 CFR §.
(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation. An investigator is required to prepare and maintain adequate and accurate 4 player local games steam histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Training and Continuing Education. Cloud-based clinical trial management system that manages the operational data for small to mid-sized sites. Training and Continuing Education. At a minimum, you should include a description of the security measures 21 cfr 312.62 and 812.140 to protect the data, and a description or diagram of the electronic data flow. Quick Links: Skip to main page content. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.

21 cfr 312.62 and 812.140 - las vegas

Subpart G--Records and Reports. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart s , and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study. On-Demand Webinar Examining the NCI Cancer Center Support Grant Join us as Forte's Regina Schwind takes us through the ins and outs of the NCI Cancer Center Support Grant. You might find the links below helpful. I would like to know where on your website I can find guidelines for record keeping when running a clinical trial. Home Comprehensive clinical research management system for mid-size to large organizations with complex needs.