GREATER PHILADELPHIA: Managing Protocol Deviations

Managing Protocol Deviations

Speakers:
Sandra Hines, Global Clinical Trial Manager, PRA Health Sciences
Annette Bernstein, Sr. Manager, Quality Training Academy, Johnson & Johnson

Program Agenda:

• 6:00 PM Registration and Light Dinner
• 7:00 PM Presentation
• 7:50PM Questions and Answers
• 8:00 PM Close and Networking

Program Description:
This interactive presentation gives practical advice on identifying and documenting protocol deviations. The one hour session includes two hands on practice scenarios.

Upon completion of this Seminar, attendees should be able to:

• List three individuals who can identify and are responsible for documenting and following up on protocol deviations
• Document a protocol deviation, determine next steps to be taken and develop a corrective action plan
• Provide examples to educate the clinical trial staff to prevent the recurrence of a protocol deviation

Target Audience:

• CRCs
• CRAs
• Investigators
• Auditors
• Project Managers
• Regulatory Affairs/Compliance
• Data Managers (Site, Sponsor, CRO)
• Medical Monitor, Medical Officer, Project Physician
• Quality Assurance

Registration Cost:
$15 for Chapter Members
$20 for ACRP Members
$25 for Non-Members

Contact hours: 1.0 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.

To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:

• $0 Chapter Members
• $15 ACRP Members
• $30 Non-Members

Refund Policy: Not applicable

Level: Not Specified