Clinical Investigator GCP & Trials Management Program
for Clinical Investigators and Key Research Staff

Program Information Program Description How to Register Agenda

Program Information

December 5 and 6, 2013 Marriott Tampa Waterside 700 South Florida Avenue Tampa, FL 33602 Hotel: 813 221 4900 Reservations: 800 228 9290 SoCRA’s hotel room rate of $159 S/D USD (plus applicable taxes) is available until November 1, 2013, or until the SoCRA room block is filled.

Registration Fees:

Member Fee- $625

Non-Member Fee*- $700
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA

Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 13.2 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 13.2 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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: 400

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Program Description

GOAL: The Society of Clinical Research Associates (SoCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop is to assist Clinical Investigators and key research staff in improving their skills and their understanding of the responsibilities of the clinical research site. This program is intended to share information and create opportunity for dialogue among clinical investigators, key research staff and program faculty. The intent of which is to enhance the participants’ ability to perform quality clinical research according to existing regulations and guidelines. This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).

OBJECTIVE: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.

LEARNING OBJECTIVES: Upon completion of this course the attendee should be able to:

• Describe the Drug Development Process
• Discuss Investigator and investigational site responsibilities related to regulations and ethics
• Describe the Protocol Development Process
• Describe the Research Grant Proposal Development Process
• Discuss the Informed Consent Process
• Explain Development of Informed Consent Forms: Rights, Rites, and Rewrites
• Describe Investigator-Initiated Research Projects
• Discuss Safety Reporting and Adverse Events / Serious Adverse Events
• Explain Source Documentation and Research Record Management
• Discuss the Financial Management of Study Funds
• Discuss the Elements Related to Successful Successful Clinical Study Agreements
• Describe the Basic Requirements of Monitoring Visits and Audits
• Discuss the Development and Implementation of Standard Operating Procedures

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How to Register

Click HERE to Register Online* Note: If you experience difficulties, please use the PDF form.

Click Here to view/print the Program Registration Form in Adobe PDF.

*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 $435 refund.
• 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 program 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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Agenda

Click Here to view/print the 2012 Workshop Agenda in Adobe PDF format.

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