APOC stands for Authorised Point of Contact. An APOC is a person who reviews and authorises changes where applicable.
CDM stands for Clinical Data Management and is a critical phase in clinical research which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.
CRA stands for Clinical Research Associate. CRAs are also referred to as a clinical monitor or trial monitor.
eCRF stands for Electronic Case Report Form and is an electronic questionnaire specifically used in clinical trial research for recording clinical trial data.
GCP stands for Good Clinical Practice. GCP is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
GDP stands for Good Documentation Practice. It's main purpose is to describe standards by which documents are created and maintained.
HIPAA stands for Health Insurance Portability and Accountability Act. HIPAA does the following:
- Provides the ability to transfer and continue health insurance coverage for millions of American workers and their families when they change or lose their jobs;
- Reduces health care fraud and abuse;
- Mandates industry-wide standards for health care information on electronic billing and other processes; and requires the protection and confidential handling of protected health information
The MHRA are the Medicines and Healthcare Products Regulatory Agency. The MHRA review and authorise products and provide licensing.
QA stands for Quality Assurance and is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers.
A query is a means of highlighting a discrepancy with data that needs to be resolved.
SAE stands for Serious Adverse Event in human drug trials is defined as any untoward medical occurrence at any dose that:
- Results in death
- Is life-threatening
- Requires inpatient hospitalisation or causes prolongation of existing hospitalisation
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Requires intervention to prevent permanent impairment or damage
SDV stands for Source Data Verification and is the process of verifying data.
SOP stands for Standard Operating Procedure and is a set of step-by-step instructions compiled by an organisation to help workers carry out complex routine operations.
Clinical trials are sponsored or funded by various organisations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health and the Department of Veterans Affairs.
SUARF stands for Site User Administration Request Form. A SUARF is a form to modify or create user accounts for an entire site.
UARF stands for User Administration Request Form. A UARF is a form to modify or create user accounts for a study.