What is TA in clinical trials?

What is TA in clinical trials?

TA Scan is a comprehensive, web-based clinical business intelligence tool that aggregates and analyzes clinically relevant public and private data to facilitate and accelerate data-driven decision-making for all aspects of clinical study planning and implementation through data insights and analytics.

What is IRB clinical trial?

Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects.

What are the ICH GCP guidelines?

The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.

What is SAE reconciliation?

SAE data reconciliation The process of comparing key safety data variables between the drug or device safety SAE database and the clinical database in order to identify any discrepancy, determine whether a discrepancy is acceptable or not and, if acceptable, document the discrepancy.

What is the difference between IRB and IEC?

There are two types of IRBs/IECs: local and central. Local IRBs/IECs are functions of the academic institutions that conduct research and review only their trials, while central IRBs/IECs provide review services for multiple entities. Some clinical trial investigators may not have access to a local IRB/IEC.

What is the difference between ICH and GCP?

ICH-GCP states that the monitor should be the one to verify the legibility of documents, while Indian GCP states that the monitor also needs to inform the Sponsor and Ethics Committee for any violations from the protocol.

What is SAE in PV?

Introduction. A Serious Adverse Event (SAE) is any untoward occurrence in a patient given a pharmaceutical product and that at any dose: • Results in death,

How do I report SAE in clinical trials?

According to the DCR-6th Amdmt,[3] the investigator should report all SAEs to the drug regulatory body of India (DCGI), sponsor of the trial, and the concerned EC that approved the trial protocol within 24 h of occurrence of the SAE.

What are ICH GCP principles?

What do you need to know about ClinicalTrials.gov?

ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. IMPORTANT: Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits.

Where can I find results of clinical trials?

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

How many clinical trials are there in the world?

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Explore 322,878 research studies in all 50 states and in 209 countries. ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine.