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: 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 firstname.lastname@example.org.
Binder-option format: Purchasers will receive the electronic format as noted above plus a 3-ring binder with cover art and labeled tabs for custom SOP assembly and organization shipped separately within one business day. Additional shipping charges will apply. (Please note: print copies of the generic SOP documents and forms are not available or included in the binder.)
Return policy: SOP electronic files are non-refundable and are not reissued if deleted, misplaced or lost. To reissue, full price applies. There are no refunds on any SOP binder, regardless of condition. If you experience a problem with the file or it is determined to be corrupt, please contact Customer Service, as noted above.
View the return policy.
About this SOP:
Every sponsor of clinical trials is ultimately responsible for the safe and ethical conduct of clinical trials, but in a complex and changing regulatory environment it can be time-consuming and difficult to write effective SOPs that will meet all the necessary and rigorous requirements while complying with applicable regulations.
Now in its second edition--with updates to more than half of all SOPs and forms—Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials is the industry’s only SOP solution available to aid organizations in implementing essential policies and procedures to comply with all federal and international regulations and good clinical practices to ensure the conduct of safe, effective and successful clinical trials.
SOP highlights include:
- 31 SOPs and 82 accompanying forms covering nine sections from general administration and clinical protocol development to study startup and quality assurance
- New risk-based monitoring SOPs with revised plans to include RBM
- New CAPA plan information and forms
- Revised site selection and feasibility SOPs with new evaluation and qualification forms
- Site initiation visit and training updates with new SIV reports and training logs
- Revised CRO/vendor management SOPs
- Financial disclosure updates
- New electronic medical record details
- Updated FDA guidance documents
- And much more!
- Professionals at pharma and biotech companies involved with clinical trials
- 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: