Electronic format: Purchasers will receive an email upon order completion (if received during normal business hours, Monday-Friday, 8 a.m.-3:30 p.m. EST) containing two documents: a Word file with SOP template and instructions and a PDF licensing agreement. Purchasers must provide an active email address during checkout registration. If you experience problems with the SOP file, please contact email@example.com.
Return policy: SOP electronic files are non-refundable and are not reissued if deleted, misplaced or lost. To reissue, full price applies. If you experience a problem with the file or it is determined to be corrupt, please contact Customer Service, as noted above.
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About this SOP:
First published in 1998, Standard Operating Procedures for the Conduct of Clinical Research has become the industry’s foremost resource for investigative sites seeking to comply with the latest FDA regulations and ICH GCP guidelines. Now in its third edition with updates to 60% of the forms and 40% of the content, this critical SOP has been revised to help sites better address organization-specific requirements, implement critical procedures to ensure clinical trial integrity and patient safety, and prepare for random agency inspections.
This customizable template includes study management materials, evaluation forms, job descriptions, checklists and detailed procedures, including newly updated content on:
- Investigator responsibilities including the Form FDA 1572 and safety/protocol violation reporting
- Human subject protection regulations and guidance for IRBs
- Informed consent requirements
- Unique expectations for medical device clinical investigations
- All investigative site staff involved in conducting, coordinating and monitoring clinical research
- Principal and sub-investigators, clinical research coordinators
- Professionals involved in clinical operations or clinical affairs
- Quality assurance and regulatory professionals
- Professionals involved with compliance to FDA, ICH and GCP guidelines
Other SOPs in this series: