Training Program Title

Worksheet: Audit Readiness

Contributor

Forte MarketingFollow

CTSA Hub Administered

no

Contact Information

marketing@forteresearch.com

Training Program Description

Having plans in place to outline procedures, documentation and key roles and responsibilities is vital when preparing for an FDA audit.

One way your site can prepare is to develop an audit-readiness checklist. This provides a guide for staff to use to ensure your processes are followed.

The audit readiness checklist includes:

  • Collecting info for your inspection
  • Notifying key staff
  • Preparing your site for an audit
  • Gathering and delivering documents

Competency Keywords

Clinical research, Clinical trial, Audits, Monitoring

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Study and Site Management

Delivery Method

Online

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Frequency

On demand

Associated Assessment

no

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