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Official Course
Description: MCCCD Approval: 6-24-08 |
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CRC291
2008 Fall – 2010 Summer II |
LEC 4.0
Credit(s) 4.0 Period(s) 4.0 Load Occ |
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Monitoring
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Basic
monitoring skills and responsibilities required of the Clinical Research
Associate (CRA). site selection and Initiation, routine monitoring and
close-out visits; audit techniques and preparations; expectations and
professionalism; monitoring plans, Standard Operating Procedure (SOP)
adherence, training of sites, travel expectations and conduct; sponsor
interactions (acting as a liaison); source document verification; review of
patient charts; use of electronic systems; monitoring reports and letters;
adverse event monitoring and reporting; recruitment and retention. Prerequisites: CRC290. |
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Go to Competencies Go to Outline
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MCCCD
Official Course Competencies: |
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CRC291 2008
Fall – 2010 Summer II |
Monitoring |
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1.
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Prepare a Monitoring Plan based on a study timeline. (I) |
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2.
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Describe potential conflicts between sites and sponsors
and create a resolution plan. (I, III) |
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3.
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Write a sample monitoring report for each of the
following: Site Initiation Visit, Routine Monitoring Visit and Close- Out
Visit. (I, III) |
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4.
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Describe the professionalism and etiquette required of a
CRA. (I, III, IV) |
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5.
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Audit a patient chart based upon protocol adherence and
Food and Drug Administration (FDA) regulations, Good Clinical Practice,
International Conference of Harmonisation (ICH)
guidelines, sponsor and site SOP. (I, III, IV) |
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6.
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Compare and Contrast monitoring objectives across
therapeutic disciplines. (I, IV, V) |
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7.
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Create an interview questionnaire to be used during the
site selection process. (II) |
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8.
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Describe the typical FDA audit and apply the process to a
mock site audit. (II) |
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9.
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Explain the CRA's role in database locks and interim
analyses. (II, III) |
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10.
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Create a template for the following letters: Confirmation
of Visit, Routine Follow-up Visit, Close-Out Visit, Action to Address Issues.
(II, III) |
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11.
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Develop a Monitor's Tool Chest consisting of checklists,
charts and job aides to assist in a Site Initiation Visit, Routine Monitoring
Visit and Close-Out Visit. (II, IV) |
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12.
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Explain the process for site selection and the roles
associated with the Clinical Research Associate (CRA). (II, V) |
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13.
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Design a study and site recruitment strategy based upon an
assigned protocol. (V) |
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14.
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Review and discuss ancillary items common to clinical trails. (V) |
Go to Description Go to top of
Competencies
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MCCCD
Official Course Outline: |
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CRC291 2008
Fall – 2010 Summer II |
Monitoring |
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I. Monitoring basics A. Roles of the In-House
CRA, Field CRA, Lead CRA and project manager B. Review of a typical
sponsor hierarchy and where the CRA fits in C. CRA as a single point of
contact/site managers D. Safety reporting:
serious adverse events versus adverse events and product complaints E. Differences across
therapeutic disciplines F. Monitoring in
Specialties: Dental, Ophthalmology and Investigator-Initiated studies G. Monitoring Plans H. Professionalism I. Monitoring Reports J. Monitor Auditing: Source
Documents versus Case Report Forms II. Monitoring tools A. Tools for conducting
Site Initiation Visits (SIV), Routine Monitoring Visits (RMV) and Close-Out
Visits - Creating a Monitoring Tool Chest B. Site Selection;
interviews and questionnaires C. Audit Preparation:
Sponsor versus FDA D. Work load assessment,
expense reporting and travel E. Electronic resources and
utilizing the web III. The role of the
liaison A. Methods of communication
B. Study start up for sites
C. Conflict resolution D. Monitoring visit
follow-up E. Interim analyses and
database locks E. Sponsor/Contract
Research Organization (CRO) expectations of a CRA. IV. Training for CRAs A. Sponsor/CRO SOP's B. External resources and
continuing education C. Study specific versus
therapeutic specific D. Preparation for
certification; sponsor versus industry expectations V. Ancillary items A. Recruitment and
retention B. Laboratory C. Cardiology
(electrocardiograms) D. Imaging (Magnetic
Resonance Imaging, Proton Emission Tomography, Computed Tomography,
ultrasound, radiographs and nuclear imaging) and therapeutic specific
requirements E. Documentation, storage
and resupply of clinical trial material. F. Electronic and Web based
systems: eDiaries, questionnaires, online study
databases, electronic data capture/management systems and central recruitment
vendors. |
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