Clinical Investigator
Clinical Investigator GCP & Trials Management Conference
for Clinical Investigators and Key Research Staff
December 4 and 5, 2008
Hilton Clearwater Beach
400 Mandalay Avenue
Clearwater Beach, FL 33767
Phone: 727.461.3222
Fax: 727.461.0610
SoCRA hotel room rate of $159 USD plus taxes is available until four weeks prior to the course or until the SoCRA room block is filled.
$625 (Member Fee)
$700 (Non-member Fee - includes SoCRA annual membership) |
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Statement for Continuing Education Credit Hours
SoCRA designates this educational activity for a maximum of 12.5 Continuing Education Credit Hours for SoCRA CE, Nurse CNE, and Physician Category 1 CME.
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: 070-3-A-07
SoCRA Course Series: 400
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Target Audience: Physicians, Clinical Investigators, Research Coordinators/Associates
Learning Objectives: The attendee should be able to:
- Describe the Drug Development Process
- IND to NDA and Phase I to Phase IV
- Discuss Investigator Responsibilities Related to Regulations and Ethics
- FDA and DHHS Regulations
- GCP and ICH Guidelines
- Institutional Human Subject Review
- Informed Consent Process/Development
- Describe the Protocol Development Process
- Applicable Regulations
- Formatting and Presentation
- Describe the Research Grant Proposal Development Process
- Suggested Content and Format
- Addressing Research Goals
- Discuss the Informed Consent Process
- Why a Process
- When does it Begin
- Explain Source Documentation and Research Record Management Requirements
- Documentation Requirements
- Case Report Forms
- Data Clarification and/or Query Forms
- Record Retention
- Monitoring Site Visits
- Discuss Safety Reporting and Adverse Events / Serious Adverse Events
- Definitions
- Adverse Events
- Serious Adverse Events
- Reporting Requirements
- Explain Development of Informed Consent Forms: Rights, Rites, and Rewrites
- Use Checklists
- Re-Write for Plain English
- Proof for grammar and Syntax
- Test and get Feedback
- Describe Investigator-Initiated Research Projects
- Protocol Development
- Peer Review
- Publication
- Data Capture Procedures
- Securing Financial and Clinical Resources
- Discuss the Elements Related to Successful Clinical Study Agreements
- The most common and problematic terminology inherent in agreements with research sponsors
- Negotiating terms and tools that will inform and educate the attendee to negotiate contracts
- Replacement terminology that will assure better understanding and long-term compatibility
- Discuss the Financial Management of Study Funds
- Describe the Basic Requirements of Monitoring Visits and Audits
- Rationale and issues surrounding the monitoring visit and the audit process
- Prepare for both the monitoring visit and the audit.
- Discuss the Development and Implementation of Standard Operating Procedures
- Regulations and Guidelines
- Philosophy and Rationale
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The Workshop Agenda is available in Adobe PDF format, which can be viewed using the
free-download of Adobe Acrobat Reader. (Click Here to Download this
FREE software.)
Click Here to view/print the December, 2007 Workshop Agenda in Adobe PDF format.
Note: The 2008 agenda will be posted as soon as it becomes available.
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Click
HERE
to register online!
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The Workshop Registration Form is available in Adobe PDF format, which can be viewed using the
free-download of Adobe Acrobat Reader. (Click Here to Download this
FREE software.)
Click Here to view/print the December Workshop Registration Form in Adobe PDF format.
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