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Randomized Control (RC) Study

A type of scientific experiment - a form of clinical research - most commonly used in testing the safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy or effectiveness of healthcare services (such as medicine or nursing) or health technologies (such as pharmaceuticalsmedical devices or surgery). Study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study. Random allocation is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed up in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, follow-up calls, etc. should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments."

RC Annual Accrual Goal

The estimated number of U-M accruals per year for the study.

RC Total Accrual Goal (Lower)

When applying this information in OnCore, enter the U-M site accrual goal for the study. This value will change if the U-M site accrual goal is modified. Set both RC Total Accrual Goal (Upper) and RC Total Accrual Goal (Lower) to the same value.

RC Total Accrual Goal (Upper)

When applying this information in OnCore, enter the U-M site accrual goal for the study. This value will change if the U-M site accrual goal is modified. Set both RC Total Accrual Goal (Upper) and RC Total Accrual Goal (Lower) to the same value.

Recruiting

The period during which a trial is attempting to identify and enroll participants. Recruitment activities can include advertising and other ways of soliciting interest from possible participants. See recruitment status and enrolling.

Recruiting Methods

Materials, compensation, and other practices or procedures used to inform potential participants about research.                                  

Methods for recruiting research participants are generally distinguished from those of marketing, advertising, or public relations’ efforts, which have promoting a product, service, or idea as goals.

Recruitment Bonus

Payment, merchandise, or other gift or service offered by a sponsor as an incentive or reward to an organization, investigator, or key personnel conducting research designed to accelerate recruitment that is tied to enrollment rate, timing, or numbers.

Recruitment Materials

Announcements; advertisements; flyers; posters; scripts for telephone or other oral communication; letters or email messages; bulletin board tear-offs; Internet postings; newspaper, radio, television, or video broadcasts, or other media used to attract potential participants for research.

Recruitment Status

Indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:                                  

  • Not yet recruiting: participants are not yet being recruited or enrolled
  • Recruiting: participants are currently being recruited and enrolled
  • Enrolling by invitation: participants are being (or will be) selected from a predetermined population
  • Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
  • Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)
  • Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
  • Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
  • Withdrawn: study halted prematurely, prior to enrollment of first participant

Regulatory Compliance

Following the rules set by a governing body.  There is a category called ‘continuing non-compliance’ where an investigator or study team repeatedly fails to follow the regulations.  For example, year after year they are late in submitting their scheduled continuing reviews, therefore their study lapses each year.

Regulatory Concern

As it relates to the need to report to the IRB, this would be an issue or incident of non-compliance with laws and regulation or to an incident or information that regulations require an IRB consider. In the ORIO guidance the term is used as a criterion for determining what kinds of submission should be sent to the IRB within 7 days. Examples include but are not limited to:                                  

  • Unanticipated problems.
  • Deviations from the research in order to eliminate hazards to subjects or others.
  • New information about safety concerns.
  • Failure to obtain consent.
  • Documenting informed consent of a non-English speaking/reading subject or the legally authorized representative of the subject on an English-only informed consent document.
  • Improper training of study team (e.g., the PI did not require new staff, fellows, or students to complete the appropriate PEERRS human subject modules).

Regulatory Non-Compliance

Failure to adhere to regulations, policies, procedures or special conditions related to the conduct of research. Examples of such noncompliance include, but are not limited to, failure to obtain/maintain approval for research; coercion of human subjects; performing unapproved procedures; and conducting research at unapproved sites.

Relatedness (adverse events)

An assessment regarding the causal relationship between a drug or intervention and an adverse event.

EVENTS RELATED

Definitely Related  

  • The event is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
  • The event follows an obvious sequence of time, from the drug’s administration, device’s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure.
  • The event ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting).
  • The event includes data that was only collected for the study.
  • The event included disturbing or upsetting questions that the subject was asked for the purpose of the research.

Probably Related

  • The event is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
  • The event follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure.

Possibly Related

  • The event is a lesser known or possible effect of the drug, device, or procedure.
  • The event occurred within a sequence of time from the drug’s administration, device implantation and/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event could be explained by the characteristics of the population under study.

EVENTS NOT RELATED 

Unlikely Related

  • The event is NOT a previously known or suspected effect of the test drug, device, or procedure.
  • The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
  • The event can be readily explained by the characteristics of the population under study.

Unrelated

  • The event is NOT known to be an effect of the test drug, device, or procedure.
  • The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
  • The event can be readily and easily explained by the characteristics of the population under study.
  • Subject never received study drug, study device, or underwent research study procedure.

Remuneration

Payment for participation in research. It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries. Also known as Compensation.

Renewal

Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.

Repository

Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.

Research

Under HHS Regulations (46.102) research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. For example, some “demonstration” and “service” programs may include research activities.

Under FDA Regulations (21 CFR 56.102) the term “clinical investigation” is synonymous with “research” and is defined as “any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Food, Drug and Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Clinical investigations regulated by the FDA under Sections 505(i) and 520(g) of the Act, include investigations of food, dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. The term “clinical investigation” does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part. Research is subject to 21 CFR 50 and 56 when it involves the use of any drug other than the use of an approved drug in the course of medical practice. Research is subject to 21 CFR 50 and 56 when it involves the use of any medical device other than the use of an approved medical device in the course of medical practice.

Research Performance Site

Location/site at which human subjects research may be performed because of an understanding of the local research context and appropriate oversight mechanisms that ensure protection of research participants.

Respect for Persons

An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and persons with diminished autonomy are protected.

Retrospective Studies

Research conducted by reviewing records (i.e., birth and death certificates, medical records, school or employment records) or information about past events elicited through interviews with persons who have, and controls who do not have, a disease under investigation.

Review (of research)

The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.

Review Type

Studies will go through Administrative and/or Scientific Review and this should be documented in OnCore. To do so, select Administrative Only or Scientific (Administrative and Scientific). NOTE: Administrative Only is used when the protocol has already undergone scientific peer review by a recognized authority. Scientific is used when the protocol has not been peer-reviewed, indicating that a scientific review is needed in addition to the administrative review.

Revision

A modified and resubmitted request for funding for a project that was previously not funded either because it was denied by the sponsor or withdrawn by the principal investigator.

Risk

The probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.” See also “Minimal Risk.”

Risk Benefit Ratio

The risk to individual participants versus the potential benefits to the individual and/or society. The risk/benefit ratio may differ depending on the condition being treated.  The IRB must determine that the risk benefit ratio of a research project is sufficiently favorable in order to approve the research, and reexamines that determination in light of adverse event, other reportable incidents, and unanticipated problems.

Routine (Not-for-Cause) Review

An assessment or examination of something (e.g., a practice or procedure) with the possibility or intention of instituting change if necessary.

Routine Research Educational and Regulatory Review (RRERR)

Routine Research Educational and Regulatory Review (RRERR) conducted by the Office of Human Research Compliance Review (OHRCR)

RSH - Allowed Procedures Section

You can use this table to specify the allowed procedures for this study, as well as the number of times each procedure is allowed.

SARA

Senior Associate Regulatory Analyst

Scheduled Continuing Review (SCR)

SCRs are completed through eResearch and are required to be submitted and approved prior to expiration. See also Continuing Review.

Sequence Number

Sponsor-provided subject identifier for this clinical trial

Serious

  • Refers to the outcome of an adverse event.
  • An event is "serious" if it adversely alters the risk-benefit relationship of the research.

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any adverse experience occurring at any dose or level of participation that results in any of the following outcomes:

  • Results in death,
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization,
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly/birth defect.
  • An unexpected result of therapy or other intervention that is severe, life threatening, or fatal, corresponding to grades III, IV, or V using NCI/CTC Common Toxicity Criteria.

Serious Non-Compliance

Non-compliance that has the potential to increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subjects protection program. Examples of serious noncompliance may include, but are not limited to: conducting or continuing non-exempt human subjects research without IRB approval; lack of legally effective informed consent from research participants; failure to report or review serious adverse events, unanticipated problems, or substantive changes in research; or inappropriate oversight of the research to insure the safety of human subjects and the integrity of the research/data.

Severe Social or Psychological Trauma

Loss of job, insurance, benefits; criminal prosecution, stigmatization of community/group, destruction of familial/social relations.

Severe-Serious Distinction

Serious adverse events result in death, disability, hospitalization (or prolongation of a hospital stay), or birth defects. Therefore, an adverse event that in and of itself would be graded as mild or moderately-severe becomes a serious adverse event if it leads to one of those outcomes. For example, a case of myelosuppression could require prolongation of an existing hospitalization, making it a "serious AE" for reporting purposes even if the myelosuppression was itself only moderately severe (Grade II). Compare to a subject experiencing a migraine after a hormone injection-the patient might consider the migraine to be severe, but if it did not result in hospitalization or other serious problems, it is not reported as a serious adverse event. See Serious Adverse Event and Severity.

Severely Debilitating

Refers to diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of limb, loss of hearing, paralysis, or stroke).

Severity

An assessment regarding the intensity of an Adverse Event (rating the event mild, moderately severe, severe, life threatening or fatal; or Grade I, II, III, IV or V).

Short Form

A written document stating that the elements of informed consent required by regulation have been presented orally to the participant or the participant's legally authorized representative. The short form consent document must be written in a language understandable to the participant or the participant's legally authorized representative.

Short Title

A study requires a short title in OnCore which involves the reduction of the full study title to a logical description that is no more than 100 characters. ***It is necessary to include RESEARCH, at the beginning of the title. Including this prefix is required, as it drives the downstream MiChart billing process.*** The Short Title is the description displayed in several OnCore reports such as Data Table 4 for cancer centers.

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