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Glossary of Useful Study Terms and Abbreviations

Dartmouth-specific Research-related Abbreviations

BOA Business Operations Associate
CCRC Clinical Cancer Research Committee (at the NCCC)
CIS Clinical Information System (DHMC's electronic medical record)
CPHS Committee for the Protection of Human Subjects (Dartmouth's IRB)
CTO Clinical Trials Office
MCA Medical Coverage Analysis
NCCC Norris Cotton Cancer Center
OCR Office of Clinical Research (at the NCCC)
SDMC Safety and Data Monitoring Committee (at the NCCC)
SOC Standard of Care
STV Study-related charge that can be billed to Medicare or to a 3rd party payer
STY Study-related charge that is billed directly to the study budget

 

Common Clinical Research Abbreviations

AE Adverse Event
AAHRPP Association for the Accreditation for Human Research Protection Programs
CCRC Certified Clinical Research Coordinator
CCRA Certified Clinical Research Associate
CCRP Certified Clinical Research Professional
CDC Centers for Disease Control and Prevention
CITI Collaborative IRB Training Initiative
CFR Code of Federal Regulations
CRA Clinical Research Associate (a/k/a Study Monitor)
CRC Clinical Research Coordinator
CRF Case Report Form
CRO Contract Research Organization
CV Curriculum vitae
DARF Drug Accountability Record Form
DHHS Department of Health and Human Services
DSMB Data Safety Monitoring Board
DSMP Data Safety Monitoring Plan
FDA Food and Drug Administration
GCP Good Clinical Practice
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
HIPAA Health Insurance Portability and Accountability Act of 1996
IB Investigator's Brochure
ICF Informed Consent Form
ICH International Conference on Harmonization
IDE Investigational Drug Exemption
IND Investigational New Drug Application
IRB Institutional Review Board
JCAHO Joint Commission on Accreditation of Healthcare Organizations
NCI National Cancer Institute
NDA New Drug Application
NIH National Institutes of Health
OHRP Office of Human Research Protections
PHI Protected Health Information
PI Principal Investigator
QA Quality Assurance
QC Quality Control
ROPI Report of Prior Investigations
SAE Serious Adverse Event
SOP Standard Operating Procedures
Sub-I Sub-investigator

 

Common Study Terms

Amendment: Permanent, intentional action or process that revises/amends a previously approved research protocol and receives IRB approval prior to implementation.

Adverse Event: Any unfavorable or unintended event associated with a research study.

Case Report Forms: Study documents that capture all the data required by the protocol for each subject. The PI is responsible for ensuring that data are accurate. During audit or review, a monitor will verify the data on a CRF, using original source documentation.

Consent Form: A document containing all elements of a research study, explained in lay language. The consent form must be signed prior to participation in any study activity.

Deviation: A one-time, unintentional action/process that departs from the IRB-approved protocol. A deviation involves a single incident and is identified retrospectively, after the event occurred.

Documentation: All forms of records that explain the study methods, conduct, and results, including adverse events, study actions, IRB approvals, deviations, and unexpected events.

Exception: A one-time, intentional action or process that departs from the IRB-approved study protocol, intended for a single occurrence.

FDA Form 1571: Also referred to as "statement of sponsors." The list of commitments and conduct required of the study sponsor of a drug or biologic study.

FDA Form 1572: Also referred to as "statement of investigator." The list of commitments and conduct required of the PI performing a drug or biologic study

Good Clinical Practice (GCP): The international standards for ethical conduct of research involving human subjects. GCP standards aim to ensure the ethical and scientific integrity of the study design, process, monitoring, recording of data, auditing, data analysis, and reporting of study results. GCP standards provide guidelines aimed to prevent mistakes in data collection and documentation.

Institutional Review Board: An appointed ethical committee responsible for reviewing each human subject protocol to ensure the ethical protection of these subjects.

Investigator's Brochure: The relevant clinical and non-clinical data compiled on an investigation drug, biologic, or device.

Monitoring: The review of a study to ensure ethical conduct, proper collection and documentation of study results, appropriate records of study procedures and subject interactions, and compliance with the approved protocol.

Protocol: The documentation of a research study's objective, design, methods, statistics, and organization.

Report of Prior Investigations (ROPI): The ROPI document is included in the IDE submissions and includes reports of all prior clinical, animal, and laboratory testing of the device. It must be comprehensive and adequate to justify the proposed investigation.

Serious Adverse Event: Any event resulting in death, a life-threatening situation, hospitalization, or prolonged hospitalization, disability, incapacity, or congenital defect.

Sponsor: The person or entity who initiates a clinical investigation. This person or entity may not actually conduct the investigation.

Source Documentation: The record or location where study data are first recorded. Source documentation may include original results, certified copies of results, observations, or other information needed to reconstruct and evaluate a study. Source documentation is used to verify data records on case report forms.

Standard Operating Procedures (SOPs): Written instructions for the management and conduct of clinical trial processes. SOPs ensure that processes are carried out in a consistent and efficient manner.

Subjects: The people enrolled in clinical trials.

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