{"id":58,"date":"2024-10-08T21:11:08","date_gmt":"2024-10-08T21:11:08","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/?page_id=58"},"modified":"2024-11-20T17:53:49","modified_gmt":"2024-11-20T17:53:49","slug":"glossary","status":"publish","type":"page","link":"https:\/\/az.research.umich.edu\/medschool\/glossary\/","title":{"rendered":"Glossary"},"content":{"rendered":"<div class=\"gb-container gb-container-8cdeb2d3 container-contained\">\n\n<h1 class=\"gb-headline gb-headline-ceb97fad gb-headline-text\">Search the Glossary<\/h1>\n\n\n<div class=\"gb-container gb-container-c23a2728\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-97348a6f\">\n<div class=\"gb-grid-column gb-grid-column-b22495e9\"><div class=\"gb-container gb-container-b22495e9\">\n<div class=\"facetwp-facet facetwp-facet-search facetwp-type-search\" data-name=\"search\" data-type=\"search\"><\/div>\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-7d0deaa0\"><div class=\"gb-container gb-container-7d0deaa0\">\n<button onclick=\"FWP.refresh()\" class=\"gb-button btn-primary fwpbutton fwp-submit\">Search<\/button>\n\n<\/div><\/div>\n<\/div>\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-a261710a\">\n<div class=\"gb-grid-column gb-grid-column-cbaa450e\"><div class=\"gb-container gb-container-cbaa450e\">\n<div class=\"facetwp-facet facetwp-facet-glossary_alpha facetwp-type-alpha\" data-name=\"glossary_alpha\" data-type=\"alpha\"><\/div>\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-0d3e8fa9\"><div class=\"gb-container gb-container-0d3e8fa9\">\n<div class=\"facetwp-facet facetwp-facet-reset facetwp-type-reset\" data-name=\"reset\" data-type=\"reset\"><\/div>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-e87b2434 facetwp-template gb-query-loop-wrapper\">\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-1450 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Limited IRB Review<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>A &#8220;Limited IRB review&#8221; is required under the 2018 Revised\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/common-rule-0\/\">Common Rule<\/a>\u00a0for certain\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/exempt-human-subjects-research\/\">Exempt human subjects research<\/a>\u00a0categories. Its purpose\u00a0is\u00a0to ensure privacy\/confidentiality protections are in place with exempt research that involves the collection of sensitive, identifiable data (categories 2(iii) and 3(i)(C)).<\/p>\n<p>The &#8220;Limited IRB reviewer&#8221; must determine that, per\u00a0<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46\">45 CFR 46.111(a)(7)<\/a>, &#8220;When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.&#8221;<\/p>\n<\/p>\n\n<span class=\"related\"><strong>Related Terms:<\/strong> <a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/common-rule-0\/\">Common Rule<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/exempt-review\/\">Exempt Review<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/expedited-review\/\">Expedited Review<\/a><span class=\"sep\">, <\/span><\/span>\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-710 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">HIPAA Identifiers<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>HIPAA Protected Health Information is considered identifiable\u00a0if\u00a0any\u00a0of the following identifiers are\u00a0included:<\/p>\n<ol>\n<li>Name<\/li>\n<li>Geographic subdivisions smaller than a state.<\/li>\n<li>All elements of dates (except year) for dates that are directly related to an individual; and all ages over 89 and all elements of dates (including year) indicative of such age<\/li>\n<li>Telephone numbers<\/li>\n<li>Fax numbers<\/li>\n<li>Email addresses<\/li>\n<li>Social security numbers<\/li>\n<li>Medical record numbers<\/li>\n<li>Health plan numbers<\/li>\n<li>Account numbers<\/li>\n<li>Certificate or license numbers<\/li>\n<li>Vehicle identification\/serial numbers, including license plate numbers<\/li>\n<li>Device identification\/serial numbers<\/li>\n<li>Universal Resource Locators (URLs)<\/li>\n<li>Internet protocol (IP) addresses<\/li>\n<li>Biometric identifiers, including finger and voice prints<\/li>\n<li>Full face photographs and comparable images<\/li>\n<li>Any other unique identifying number, characteristic, or code<\/li>\n<\/ol>\n<p>For details and exceptions, see Research A-Z webpage <a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/protected-health-information-phi\/\">Protected Health Information<\/a>, heading &#8220;HIPAA identifiers.&#8221;<\/p>\n<\/p>\n\n<span class=\"related\"><strong>Related Terms:<\/strong> <a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/protected-health-information-phi\/\">Protected Health Information (PHI)<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/hipaa\/\">HIPAA<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/limited-data-set-lds\/\">Limited Data Set (LDS)<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/de-identified\/\">De-Identified<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/individually-identifiable-health-information\/\">Individually Identifiable Health Information<\/a><span class=\"sep\">, <\/span><\/span>\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-709 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Invasive Procedures<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>An\u00a0<a href=\"https:\/\/medlineplus.gov\/ency\/article\/002384.htm\">invasive procedure<\/a>\u00a0is one in which the body is &#8220;invaded&#8221;, or entered by a needle, tube, device, or scope.<\/p>\n<p>Some procedures routinely employed in clinical practice that are &#8220;minimally invasive&#8221; can be deemed to pose <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal <\/a>physical <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk <\/a>to research participants: most commonly, <a href=\"\/medschool\/guidance\/blood-draw-guidance\">blood draw<\/a> by venipuncture or specimen collection by nasopharyngeal\u00a0swab. Risk determination <a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/evaluating-risks-participants\/\">depends also on other contextual features<\/a> of the study.<\/p>\n<p><a class=\"gtip\" href=\"\/medschool\/glossary\/office-human-research-protection-ohrp\">OHRP<\/a>&#8216;s\u00a0Secretary\u2019s Advisory Committee on Human Research Protections\u00a0(<a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/index.html\">SACHRP<\/a>) offers suggested examples of &#8220;minimally invasive&#8221; procedures in a\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/attachment-a-december-12-2017\/index.html\">12\/2017 Recommendation<\/a> on revisions to the list of &#8220;<a href=\"\/medschool\/guidance\/expedited-review\">Expedited categories<\/a>&#8220;:<\/p>\n<p class=\"rteindent1\"><strong>4. Prospective collection of biological specimens, excluding blood, for research purposes by minimally invasive means<\/strong> and not requiring sedation for research purposes.<\/p>\n<p class=\"rteindent1\"><strong>Examples:<\/strong> <strong>(a)<\/strong> tissues from non-facial, non-genital skin punch biopsy with allowable local anesthesia and limited to 2mm in diameter and not requiring sutures; <strong>(b)<\/strong> Specimens collected\u00a0 by swab (nasal, oral, urethral, vaginal, rectal); <strong>(c)<\/strong> teeth if routine patient care indicates a need for extraction.<\/p>\n<p>SACHRP recommendations are\u00a0<strong>not<\/strong> regulation-level, <strong>nor<\/strong>\u00a0current official guidance from OHRP, but are often considered a reasonable basis for institutional guidance and policy.<\/p>\n<\/p>\n\n<span class=\"related\"><strong>Related Terms:<\/strong> <a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/minimal-risk-0\/\">Minimal Risk<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/noninvasive-procedures\/\">Noninvasive Procedures<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/expedited-review\/\">Expedited Review<\/a><span class=\"sep\">, <\/span><\/span>\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-708 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Noninvasive Procedures<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p><a href=\"https:\/\/medlineplus.gov\/ency\/article\/002269.htm\">Noninvasive procedures<\/a>\u00a0do not involve tools that break the skin or physically enter the body. Noninvasive procedures for research purposes are usually deemed to pose\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal<\/a> physical <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk<\/a>, though this is also <a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/evaluating-risks-participants\/\">dependent on other contextual factors<\/a>.<\/p>\n<p><a class=\"gtip\" href=\"\/medschool\/glossary\/office-human-research-protection-ohrp\">OHRP<\/a>&#8216;s\u00a0list <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/categories-of-research-expedited-review-procedure-1998\/index.html\">Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)<\/a> includes many examples:<\/p>\n<p class=\"rteindent1\"><strong>#3. Prospective collection of biological specimens for research purposes by noninvasive means.<\/strong><br \/>\n<strong>Examples:<\/strong> <strong>(a)<\/strong> hair and nail clippings in a nondisfiguring manner; <strong>(b)<\/strong> deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; <strong>(c)<\/strong> permanent teeth if routine patient care indicates a need for extraction; <strong>(d)<\/strong> excreta and external secretions (including sweat); <strong>(e)<\/strong> uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; <strong>(f)<\/strong> placenta removed at delivery; <strong>(g)<\/strong> amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; <strong>(h)<\/strong> supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; <strong>(i)<\/strong> mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; <strong>(j)<\/strong> sputum collected after saline mist nebulization.<\/p>\n<p><strong>#4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice<\/strong>, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared\/approved for marketing&#8230;.<br \/>\n<strong>Examples:<\/strong> <strong>(a)<\/strong> physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject&#8217;s privacy; <strong>(b)<\/strong> weighing or testing sensory acuity; <strong>(c)<\/strong> magnetic resonance imaging; <strong>(d)<\/strong> electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; <strong>(e)<\/strong> moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.<\/p>\n<\/p>\n\n<span class=\"related\"><strong>Related Terms:<\/strong> <a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/minimal-risk-0\/\">Minimal Risk<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/invasive-procedures\/\">Invasive Procedures<\/a><span class=\"sep\">, <\/span><a class=\"term_link\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/expedited-review\/\">Expedited Review<\/a><span class=\"sep\">, <\/span><\/span>\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-707 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">MiChart<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The patient-centric electronic health record (EHR) system used by more than 26,000 members of the Michigan Medicine community.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-706 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Title<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Equivalent to the U-M Full Title in the eResearch Proposal Management system; ultimately, this should be the title as found exactly on the contract. Entries must be 4000 characters or less.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-705 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Task List Target Date<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The expected date the document will be received and attached, or the activity will be completed. It is recommended these dates are completed when the task list is first applied to&nbsp;the protocol.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-704 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Task List Owner<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The person (or role) responsible for completing the task. This may be a particular person (user) in OnCore or a role (such as CTSU Coordinator), which allows any user in that role&nbsp;(with access to the protocol) to be notified about Active or Upcoming Tasks.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-703 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Task List Completed Date<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The date the document was actually received and attached to the protocol in OnCore, or the date the activity was actually completed. It is important to track these dates so that tasks are marked as completed and do not show up in the Active or Upcoming Task widgets in the OnCore dashboard.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-702 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Subject Related<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Subject-related events are attributable to a specific subject and are associated with specific visits.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-701 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Study Completion Date<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Final date on which data is expected to be collected at U-M.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-700 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Start Up<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Activity on a study that is not open to accrual.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-699 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Short Title<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>A study requires a short title in OnCore&nbsp;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.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-698 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Sequence Number<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Sponsor-provided subject identifier for this clinical trial<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-697 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Review Type<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>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.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-696 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">RC Total Accrual Goal (Upper)<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>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.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-695 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">RC Total Accrual Goal (Lower)<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>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.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-694 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">RC Annual Accrual Goal<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The estimated number of U-M accruals per year for the study.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-693 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Protocol-Related Costs<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The Protocol Related tab identifies all the events that relate to the operation of the protocol as a whole (IRB fees, IRB Amendment fees, Advertising fees, and Quarterly Pharmacy fees). These are fees that you would incur even without a single subject accrued.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-692 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Protocol Type<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>There are three different options for entering the Protocol Type into OnCore. When determining the Protocol Type, select from the drop-down list using the following definitions: 1. Treatment: Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions. 2. Diagnostic: Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease. 3. Other<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-691 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Protocol Target Accrual<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Overall accrual goal for the protocol, including all affiliated institutions if a multisite trial.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-690 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Protocol Staff<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Study Team members who will be engaged in the conduct of the trial as Protocol Staff<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-689 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Protocol No.<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>This number should be updated with a study HUM# when assigned. Upon receiving the trial\u2019s HUM number, DO NOT include the HUM prefix in this field. All leading zeros should be included. If not assigned during the feasibility process, enter it into the PC Console.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-688 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Protocol Coordinator<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>Individual who manages the study protocol (e.g., consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-687 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">PRMC (Protocol Review and Monitoring Committee) Approval<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>When the Medical Director Documents Review Determination as Approved<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-686 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Principal Sponsor<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The sponsor that enrollment should be attributed to for reporting purposes<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-685 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Prime Sponsor<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The original source of project funds named in the agreement, if not the Direct Sponsor. Some projects have Prime Sponsors<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-684 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Primary Management Group<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The Primary Management Group in OnCore is&nbsp;the CTSU that the trial is supported by.&nbsp;<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-683 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Primary Completion Date<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>The date that the final subject is anticipated to be examined or receive an intervention at U-M for the purposes of final collection of data for the primary outcome.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-eaf14833 gb-query-loop-item post-682 glossary type-glossary status-publish hentry\"><div class=\"gb-container gb-container-eaf14833\">\n<h2 class=\"gb-headline gb-headline-176c38c2 gb-headline-text\">Pass Thru Procedures<\/h2>\n\n<p class=\"gb-headline gb-headline-64821058 gb-headline-text\"><p>These charges are billable to the sponsor. When a procedure marked Pass Thru occurs on a subject visit, the charge appears as its own invoiceable item in the Financials Console. When added to an invoice, each Pass Thru procedure is listed as its own line item. Pass Thru charges are not included in the total calculated cost for billable milestones.<\/p>\n<\/p>\n\n\n<\/div><\/div>\n<\/div>\n\n\n<div class=\"facetwp-facet facetwp-facet-pager_ facetwp-type-pager\" data-name=\"pager_\" data-type=\"pager\"><\/div>\n\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Search the Glossary<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"1","_relevanssi_noindex_reason":"","_umich_oidc_access":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-58","page","type-page","status-publish"],"acf":[],"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/pages\/58","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/comments?post=58"}],"version-history":[{"count":0,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/pages\/58\/revisions"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=58"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}