ComplianceOnline

Issue Detection and Escalation in Clinical Trial Settings

Instructor: John (Jack) McLane 
Product ID: 702261
  • Duration: 60 Min

recorded version

$229.00
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: Jun-2012

Training CD

$299.00
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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Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

Course "Issue Detection and Escalation in Clinical Trial Settings" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

In recent years the FDA has increased the number of clinical sites and trials that have been inspected and audited.  The number of investigators under investigation or disqualified has increased.  IRBs have been inspected and issued with 483 letters.

What would happen: If the site enrolls some subjects that don't meet all the entry criteria? Have unreported safety issues?  Don't sign the CRF? Are not accurate in reporting the data?  Don't follow their own SOP?  Are these issues hidden in your monitoring reports or not there at all?   The FDA does conduct audits of the sites and will issue 483 letters to either the sites or to sponsors.   During a market review of data submitted for example an NDA they can disqualify the data if not consistent, they  can disqualify a site if they have had protocol, GCP or SOP deviations.  They can disqualify a whole study or application if the issues are systemic.  Do you have the processes to assure compliance?

This webinar will help you understand the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

Areas Covered in the Seminar:

  • Checking the investigators and IRB qualifications and training.
  • Preventive risk mitigation methods including training and monitoring sites.
  • Considerations for protocol violations.
  • Issuing protocol deviations.
  • Communication plans with issue escalations and contingency planning.
  • Monitor report templates.
  • Process maps for risk mitigations and action items including escalation.

Learning Objectives:

  • Understanding of  responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance.
  • Proactive monitoring to prevent issues.
  • Project managing risk mitigation.
  • Contingency planning.
  • Issue escalation.

Who will Benefit:

This webinar will provide valuable assistance and procedures for sponsors, clinical site managers, CROs, and clinical trial vendors (central labs, drug supply imaging service companies). The following individuals would benefit from this webinar:

  • Clinical operations
  • Project managers
  • Clinical Research Associates (CRA)
  • Clinical Trial Associates (CTA)
  • Medical monitors
  • Pharmacovigilance specialists
  • Site managers
  • Principle Investigators

Instructor Profile:

John (Jack) McLane, Ph.D. COO and VP of Clinical and Regulatory Affairs at Clinquest, Inc. has over 25 years of experience in the pharmaceutical and medical device with both large and small pharmaceuticals and CRO. He has been directly involved in over 100 clinical studies, filed numerous INDs/ IDEs and three NDA/MAA submissions. As a leader in risk assessments and mitigations he understands and implements processes in complex teams to evaluate means to reduce risks from occurring and if they occur how they will be handled.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Computer System Validation - Reduce Costs and Avoid 483s

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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