ComplianceOnline

Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How

Instructor: Charles H Pierce
Product ID: 700924
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2008

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.

Description

All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices Depending on the nature of the test agent, the length of the study or the number of sites conducting the clinical study, the "Plan" may set the "Charter" of what is called a Data and Safety Monitoring Board (DSMB) or Committee (DSMC). DSMB's and their composition play an increasingly important roll in both multi-center studies and where there is an expected or possible adverse event. The "Stopping Rules" are an important element in the Charter. The overriding reason for a carefully selected DSMB is to promote and guarantee human subject safety.

Areas Covered in the seminar:

  • The historical background of why Data and Safety monitoring is essential.
  • The purpose of the Data and Safety monitoring plan.
  • The Regulatory requirements for safety monitoring.
  • Studies requiring a formal Safety monitoring plan.
  • What does the "Charter" of a DSMB compose of?
  • What is the composition and function of a DSMB.
  • What types of studies "require" a DSMB.
  • Conflict of interest and the DSMB.

Who will benefit:

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:

  • Principal Investigators / Sub-investigators.
  • Clinical Research Scientists (PKs, Biostatisticians, ...).
  • Safety Nurses.
  • Clinical Research Associates (CRAs) and Coordinators (CRCs).
  • QA / QC auditors and staff.
  • Clinical Research Data managers

Instructor Profile:

Charles H. Pierce,, MD, PhD, FCP, CPI is "Pierce One Consulting" which is a consulting group specializing in bringing the message of GCP and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce has been in the Clinical Research Industry for 18 years, has authored a "Manual for Investigators", and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator GCP training, and medical monitoring in both drug and device studies.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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