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Clinical Science Courses
July 22 to 26, 2013
Crowne Plaza Denver
1450 Glenarm Place
Denver, CO 80202
Hotel phone: 303 573-1450
Reservations: 877 270 1393
SoCRA’s hotel room rate of $169 S/D USD (plus applicable taxes) is available until July 1, 2013 or until the SoCRA room block is filled.
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October 14 to 18, 2013
Bally's Las Vegas
3645 Las Vegas Blvd South
Las Vegas, NV 89109
Hotel phone: 702 967 4111
Reservations: 800 358 8777
SoCRA’s hotel room rate of $109 S/D USD (plus applicable taxes) is available until Sept 14, 2013 or until the SoCRA room block is filled.
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Registration Fees:
Full five day program - member - $1150 - non-member - $ 1,225
Module 1 - member - $750 - non-member - $ 825
Module 2 - member - $600 - non-member - $ 675
Non-member fee includes membership for one year
Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 35* Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 35* AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
*Module 1 AND Module 2 (full program) offers up to 35 CE (Continuing Education) credits.
Module 1 (only) offers 21 CE (Continuing Education) credits. Module 2 (only) offers 17.2 CE (Continuing Education) credits.
Accreditation Statements:
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 205-3-A-09
SoCRA Course Series: 100
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Goal: This course has been established to develop an internationally accepted standard of knowledge and understanding of the research process and related regulations, as well as medical and scientific areas related to clinical research.
Objective: The course contains two modules. 35 hours total CE available. The attendee may elect to attend one (either) or both modules.
Module I is the Regulatory / Procedural Module consisting of sessions pertaining to:
- Issues Involved in Addressing the Development Process,
- Clinical Pharmacology and Adverse Event Reporting,
- Study Development and the Research Budget,
- Good Clinical Practices,
- ICH Guidelines,
- Informed Consent,
- Preparing for an GCP Audit,
- Regulatory Affairs and IRBs (IND/NDA),
- Research Ethics, and
- Source Documentation and Administration.
Module 1 is a 3 day course which meets Monday 8AM - Wednesday 4:30PM.
Module 2 is the Medical / Scientific Module consisting of sessions pertaining to:
- Ethical Issues in Clinical Trials,
- Anatomy and Physiology,
- Cell Biology,
- Genetics,
- Clinical Laboratory Analysis,
- Epidemiology, and
- Research Statistics.
Module 2 is a 2 1/2 day course which meets Wednesday 1PM - Friday 4:30PM.
Learning Objectives: Upon completion of this (full) course the attendee should be able to:
- Discuss the Drug Development Process regarding the definitions, regulations, and processes from IND to NDA.
- Discuss the development and implementation of the International Conference on Harmonisation, the clinical research guidelines resulting from that collaboration, and how the ICH guidelines affect the clinical researcher.
- Discuss the (drug, device, biologics) development program, including protocol development, case report form design, project and program management, assessing costs and building budgets.
- Describe adverse drug reactions and adverse events, the drug development process, drug laws, statistical perspectives, specific mechanisms of drug actions, and IRB notifications.
- Discuss various perspectives and regulations regarding adherence to protocol, patient rights, informed consents, and regulatory issues related to an FDA audit.
- Discuss procedural and management issues regarding utilization and disposition of source documents.
- Discuss regulations, generally accepted policies and procedures, and audit practices associated with IRBs and the informed consent process.
- Discuss research ethics including the importance of the informed consent and the principles of medical research ethics as well as therapeutic misconceptions, randomizations, and placebos.
- Discuss cell biology including cell structure, function, and reproduction.
- Describe the development and science supporting genetics and pharmacogenetics.
- Discuss anatomy and physiology including selected body systems, organs, and how they function.
- Discuss the basic laboratory values in clinical research and their importance in the disease process.
- Discuss epidemiological and statistical issues related to the distribution and determinants of health related events in certain populations.
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Click
HERE
to Register Online* Note: If you experience difficulties, please use the PDF form.
Click Here to view/print the Course Application in Adobe PDF format.*
*SoCRA REGISTRATION POLICIES/INFORMATION:
- Non member fees include a one year membership in SoCRA.
- Membership fees are processed immediately and are not refundable.
Fees are in U.S. dollars.
- Please make checks payable to “SoCRA”
- Checks must be drawn on a U.S. bank or marked “Pay in U.S. Funds”.
- Written cancellation requests received by SoCRA at least 10 business days prior to start of course may receive a partial refund as follows:
- $800 - Module 1 and 2;
- $525 Module 1 (only);
- $420 Module 2 (only).
- We regret that refunds cannot be issued for cancellations on or after 10 business days prior to start of course.
- Taping (audio or video) is prohibited unless SoCRA’s written permission has been acquired.
- ADA - This program is accessible to persons with disabilities. Please list any special needs in the area indicated in the registration form.
- If for any reason this conference cannot be held, SoCRA is not responsible for costs incurred by attendees, such as airfares, or hotel or other reservations.
- SoCRA is an educational non-profit membership organization (corporation) - Federal Tax ID #61 1208981.
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Click Here to view the Course Agenda in Adobe PDF format.
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Click Here to view a Selected Faculty Overview in Adobe PDF format.
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