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
|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|
|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|
|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|
|ROPI||Report of Prior Investigations|
|SAE||Serious Adverse Event|
|SOP||Standard Operating Procedures|
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.