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:
Completely re-written for 2015, the all new Standard Operating Procedures for Good Clinical Practice by Sponsors of Medical Device Clinical Trials is the industry's only medical device SOP solution available that reflects best practices while addressing the latest FDA Guidance documents and current device regulations to minimize your organization's regulatory exposure and comply with industry standards.
This latest edition includes streamlined processes eliminating non-essential, non-regulatory business steps and is completely customizable for immediate integration into your company's operations.
- 27 SOPs and 62 accompanying forms covering eight sections from general administration and clinical protocol development to study startup and quality assurance
- Succinct overview of the clinical investigational process
- Important medical device development steps
- Guidance on risk-based monitoring and technology implementation
- Key elements from ISO 14155
- Revised CRO/vendor management SOPs
- And much more!
- Professionals at medical device companies involved with clinical trials and device development
- 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: