Engaged. Knowledge. Application
Informed Consent CONTENT Package
This comprehensive package includes a content reference article, auditing checklist, powerpoint presentation, and trainer instructional notes. Includes:
➢1. The Informed Consent Process: Effective Practices (Content Reference Article)
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➢2. General Informed Consent Auditing Checklist
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➢3. Informed Consent (PDF PowerPoint Training Presentation)
➢4. Informed Consent (Trainer Instructional Notes)
1. The Informed Consent Process: Effective Practices (Content Reference Article)
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An inadequate informed consent process is one of FDA’s top five (5) GCP-related inspectional observations. This 10 page article takes a lifecycle approach from discussing historical documents, which served as the basis of informed consent, to implementing an effective informed consent process. The following subject matter content below is included in the article:
➢Declaration of Helsinki
➢Nuremberg Code
➢Informed consent content
➢Subject welfare rights
➢The informed consent process
➢Administration of informed consent
➢Subject comprehension
➢Vulnerable persons
➢Minors and the process of assent
➢Informed consent form
➢Clinical study worksheet
➢Informed consent-a critical component of clinical research
➢Implications of HIPAA
➢Legal ramifications
➢Study oversight
➢Managing changes (when subjects are required to be reconsented)
2. General Informed Consent Auditing Checklist
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This five (5) page checklist contains 35+ items related to auditing informed consent documentation. This checklist is based on the following regulatory documents below:
➢FDA 21 CFR Part 50 – Subpart B Informed Consent of Human Subjects
➢FDA Compliance Program Guidance 7348.811
➢FDA Guidance for IRB and Clinical Investigators
➢ICH GCP Section 4.8
➢Canadian Food and Drugs Act Regulations (Part C, Division 5)
3. & 4. Informed Consent (PDF PowerPoint Training Presentation & Trainer Instructional Notes)
12 slide PDF PowerPoint Training Presentation based on the subject matter presented in the reference content article above. This PDF readymade presentation provides “core” subject matter content, and allows you to customize specific information within your presentation. Trainer instructional notes, which contain 21 discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.
Informed Consent CONTENT Package is only $99.00
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