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Guide to Good Clinical Practice |
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About Your Subscription
You can review this product for 30 days. Your annual subscription includes published updates at no additional charge for the 12 month subscription period. 12 updates are expected. If you cancel your subscription within 30 days of receipt, you will receive a full credit upon return of the product together with a request for cancellation.
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The Guide to Good Clinical Practice provides sponsors, institutional review boards (IRBs), clinical investigators, monitors and study site staff with the information and tools they need to conduct quality clinical trials of new drugs, devices and biologics. From explanations of laws, federal regulations and international harmonization efforts to an analysis of accepted good clinical practices, the Guide helps clinical researchers to avoid costly errors and gain faster product approval. The Guide includes sample checklists for conducting quality assurance audits, FDA forms, industry guidance documents and information sheets. Regular newsletters and Guide updates offer up-to-date news and analysis on key developments in conducting clinical research. Included in your subscription is access to clinlaw, an online database of state clinical trial requirements.
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Satisfaction Guaranteed
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| If you are not completely satisfied, for whatever reason, write cancel on the invoice and return it to us within 30 days — no questions asked. Print materials (excluding newsletters) must also be returned. If you pre-pay your subscription and decide to cancel within 30 days, we will refund your money in full. |
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Description:
Featured Topics - Sponsor/Monitor, Clinical Investigator and IRB Obligations
- Adverse Event Reporting Requirements
- FDA Monitoring
- Quality Assurance Audits
- International GCP
- Informed Consent
- Clinical Data Documentation Requirements
Table of Contents 100 Overview of Good Clinical Practice
200 Investigator Obligations
300 Information About Subjects
400 Document Requirements
500 Sponsor/Monitor Obligations
600 Evaluation of Clinical Data
700 Quality Assurance Audits
800 Institutional Review Boards
900 International Good Clinical Practice
1000 Electronic Submissions, Computer Validation
1100 FDA Monitoring
1200 Other Federal Authorities
Appendixes
Index
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