Glossary of Terms
- Accounts Payable:
- The set of systems and procedures to ensure that expenses allocated to a study are accurate, appropriate, applicable, reasonable, and within the scope and budget of the study; paid in a timely manner and; are compliant with all University regulations.
- Accounts Receivable / Reconcilliation:
- The set of systems and procedures to ensure that study revenues are invoiced and received accurately and in a timely manner; reconcile each study budget on a regular basis to ensure invoicing and receipt of all revenues related to the study.
- The schedule identifying the charges to be assessed to a funding entity for conduct of a clinical research study based on the protocol-defined work to be completed .
- Clinical Research:
- Patient-oriented research: This type of research involves a particular person or group of people or uses materials from humans. This research can include:
- Studies of mechanisms of human disease
- Studies of therapies or interventions for disease
- Clinical trials (see 'Clinical Trial' below for more details)
- Studies to develop new technology related to disease
Epidemiological and behavioral studies: These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions.
Outcomes and health services research: These studies seek to identify the most effective and most efficient interventions, treatments, and services.
- Clinical Trial:
- A prospective study involving human subjects that is designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions. Such studies may include drugs, treatments, devices, or behavioral or nutritional strategies.
- Clinical Trial Agreement - CDA or NDA
- The Confidential Disclosure Agreement (CDA)b> or Non-Disclosure Agreement (NDA) assures the sponsor or CRO that the institution will protect the confidential information against unauthorized disclosure for a period of time.
- Clinical Trial Agreement - CTA
The Clinical Trial Agreement is an agreement between the sponsor and the University to define the scope of work required by the clinical trial protocol.
Clinical trial agreements are the true legally binding contract for services agreed to by the sponsor and institution. They define specifically what will be done, to whom and when, and who will be responsible for costs.
- Clinical Trial Agreement - Master
- A Master Clinical Trial Agreement is an umbrella agreement between a sponsoring company and the University in which both parties agree upon a set of contractual terms and conditions for future clinical trials contemplated by the agreement. This alleviates the need to negotiate contractual terms for individual clinical trials. Instead, each subsequent clinical trial is contracted for based upon an already agreed to series of terms and conditions.
- Coordinator Services:
- The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
- Coverage Analysis:
- A coverage analysis (CA) is required for all clinical research in which tests, procedures, and interventions associated with the research have the potential to be invoiced to third party payers. Preparing a CA involves determining the underlying eligibility of the study for Medicare or third party coverage and reviewing clinical events specified in the protocol to determine which can be reimbursed. The initial coverage analysis (protocol billing grid) is to be completed by the investigator and submitted to the CRO for review and approval. The UB CRO will consult with investigators during review of the Coverage Analyses so that the PI's expertise and insights are reflected in the final document.
- Data Management:
- Clinical Data Management is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The primary objective of CDM process is to provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis.
- Individuals holding current UB faculty title / designation.
- Feasibility Analysis:
- Feasibility analysis is a process to ensure that the proposed study has a satisfactory chance of being successfully completed. Feasibility review applies to the actual clinical research protocol, which describes the patient population, accrual targets, trial timeline, study procedures, and involvement of human subjects. The review can be conducted by a member of the study team or by a business/financial analyst in the department. It must address all elements on the feasibility checklist and be based on verifiable data.
- Institutional Review Board (IRB)
- An IRB is any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The IRB mu st be properly constituted as identified in 21 CFR 56.107.
- Investigational Device Exemption (IDE) Requests
Investigational device exemption; allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
Notice is not required for humanitarian use devices, post-market approval studies or registries of devices other than carotid stents, or clinical studies other than those described above.
- Investigational New Drug (IND)
- Investigational New Drug is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy. The term also includes biological products that are used in vitro for diagnostic purposes. Investigational new drug application is a request for authorization from the FDA to administer an investigational drug or biological product to humans.
- The act of overseeing the progress of a clinical trial while ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, good clinical practice, and the applicable regulatory requirements.
- National Clinical Trial Number (NCT Number)
- National Clinical Trial (NCT) number, another term for the ClinicalTrials.gov registry number unique to each record. The format for the ClinicalTrials.gov registry number is “NCT” followed by an 8-digit number, e.g.: NCT00000419.
- Principal Investigator (PI)
- Principal Investigator means an individual who is responsible and accountable for conducting the clinical trial (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. The PI assumes full responsibility for the treatment and evaluation of human subjects, and for the integrity of the research data and results.
- A study plan on which a Clinical Trial or Clinical Research Study is based. The protocol identifies the specific research questions to be answered, describes the parameters of the study, and is designed to safeguard the health of the participants.
- Research Subject Advocate:
- The Research Subject Advocate (RSA) acts on behalf of study volunteers to ensure their protection during a study. People either currently enrolled or thinking of enrolling into a clinical trial should contact the RSA if there are questions or concerns with regard to confidentiality, privacy, safety, research ethics, the process of informed consent, or the rights of participants. The RSA is an available liaison between research participants, investigators, and the institutional review board (IRB) that approves a study.
- Sponsor means a person or other entity that initiates a clinical investigation, but that does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual.
- An individual who both initiates and conducts an investigation, and under whose immedicate direction the investigational drug is administered or dispensed. This term always applies to an individual. The sponsor-investigator has the regulatory resonsibilities of both the investigator and the sponsor.
- The FDA definition of sub-investigator includes any individual member of the research team who assists the investigator and makes a direct and significant contribution to the data. The determination of whether an individual should be included as a sub-investigator should be based on whether the individual is performing significant duties related to the trial.
- Subject Recruitment and Retention:
- Subject recruitment and retention are critical to clinical research programs. Subject recruitment, if not adequately planned for, can extend the development timeline by a number of years. Retention of subjects throughout the life of a clinical trial is essential in order have complete data sets for analysis and subsequent filings.