What is a post market study?
Postmarketing study commitments are studies required of or agreed to by a sponsor that are conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product’s safety, efficacy, or optimal use.
What is CMP in clinical trials?
A Clinical Monitoring Plan (CMP) is created for each study that will be monitored. The information provided below serves as a guideline for developing the clinical site monitoring plan. The levels of complexity are based on human subject risk, size, nature, and complexity of the study.
What is a CRF in research?
Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data.
What is post market assessment?
The aim of Post-Market Surveillance (PMS) is to identify whether health technologies continue to be as safe, effective or cost effective as when originally approved for market entry or reimbursement, or as compared to new health technologies under assessment.
What are post marketing activities?
Post Marketing Activities means all commitments required by the applicable Regulatory Authorities, which will be used to collect additional information, following Regulatory Approval, about the Product’s safety, efficacy, or optimal use.
What is AOR in clinical research?
NC State University’s Authorized Organizational Representative (AOR) is a college research officer within the CRO who has the responsibility and authority to conduct pre-award and/or post-award activities for sponsored work.
What is CTA in clinical research?
Back To News. CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party’s responsibilities and obligations for the clinical trial.
What is TMF Reference Model?
The Trial Master File (TMF) Reference Model is a supported initiative of the Drug Information Association’s (DIA) Document and Records Management Community and represents a single, unified interpretation of the regulations and best practices related to Trial Master Files that would be accepted by all clinical trial …