ComplianceOnline

Deviation and Violation - avoiding the impact of protocol waiver

Instructor: Ingrid Koster
Product ID: 701542
  • Duration: 60 Min

recorded version

$249.00
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: Feb-2010

Training CD

$450.00
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

Customer Care

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Read Frequently Asked Questions

Know Specific knowledge about the concept of deviations and violation of protocols and its implications.

Why Should You Attend:
Federal regulations require that no changes be made in the research protocols without the approval of the IRB, except when necessary to eliminate apparent immediate hazards to humans. There should be a solid knowledge of the protocol approved by the IRB to avoid this potential security risk of the patient clinical study. Misuse or tampering with records for the protocol should always be, primarily because of its quantity or types that cause bias in the data of the study and also impact the quality of survey data for analysis. Moreover it is very important establish the involved team roles to ensure safety for all participating subjects in the conduct of the research follow the IRB-approved research protocol.

This web training intends to provide specific knowledge about the concept of deviations and violation of protocols and also its implications; It will also be discussed the measures to minimize the risk of the integrity of the protocol and regulatory aspects implicated for the application of a new drug. It will also be discussed the measures to minimize the risk of the integrity of the protocol and regulatory aspects implicated for the application of a new drug.

Areas Covered in the seminar:

  • Concepts of safety and welfare of research participants.
  • Description of the rights of research participants.
  • Integrity of the study design.
  • Informed Consent process.
  • Classification and examples of Protocol Deviations/Violations and definitions of key terms.
  • Examples of major and minor deviations, violations and exceptions.
  • Overview of specific reporting requirements.

Who will benefit:
This webinar intends to provide expertise regarding clinical data for any member involved in clinical trials development among Pharmaceutical Industries

  • CROs
  • Vendors
  • Study Sites
  • Steering Committees
  • Consultants
  • Regulatory agencies

Instructor Profile:
Ingrid Koster, Epidemiologist, has worked in Clinical Research operations as Investigator and also as sponsor in the Pharmaceutical Industries along almost 15 years in Latin America. Ms Koster combines her background and current position in Public Health with her expertise in Research and Development within Pharmaceutical Industries to bring to us not only experiences in Clinical Trials management in several Therapeutic Areas but important insights to improve knowledge and perception for the major points regarding Clinical Research development.

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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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