Sponsor and Contract Research Organization
Standard Operating Procedure Order Form
Check to Order / SOP Number / SOP Name / Recommended for:Start-Up / Advanced
ADM-001 / Writing and Revising Standard Operating Procedures / √
ADM-002 / Management and Approval of Critical Documents / √
BST-001 / Biostatistics Management / √
CLO-001 / Conducting Pre-Qualification Monitoring Visits / √
CLO-002 / Drug or Device Shipment, Storage and Accountability / √
CLO-003 / Conducting Study Initiation Monitoring Visits / √
CLO-004 / Conducting Interim Monitoring Visits / √
CLO-005 / Monitoring Drug or Device Accountability / √
CLO-006 / Procedures for Maintaining Patient Source Documentation / √
CLO-007 / Monitoring Paper Case Report Forms and Source Documents / √
CLO-008 / Reporting and Processing of Serious Adverse Events or Effects / √
CLO-009 / Monitoring of Final Drug or Device Accountability / √
CLO-010 / Final Drug or Device Shipment, Storage and Accountability / √
CLO-011 / Conducting Close-Out Monitoring Visits / √
COM-001 / Sponsor/CRO Corrective and Preventive Actions / √
DMT-001 / Receiving and Managing Electronic Data / √
DMT-002 / Managing Laboratory Data / √
DMT-003 / Serious Adverse Event Reconciliation Data / √
DMT-004 / Managing External Data / √
DMT-005 / User Acceptance Testing / √
DMT-006 / Clinical Data Transfer and Archive / √
REG-001 / Clinical Trial Master File / √
REG-002 / Preparing for and Conducting an Internal Process Audit / √
REG-003 / Preparing for and Conducting an Audit of Study Master Files / √
REG-004 / Preparing for and Conducting an Audit of an Investigator’s Site / √
REG-005 / Preparing an Audit Report and Subsequent Follow-up / √
REG-006 / Preparing for Audit by Client or Regulatory Authority / √
REG-007 / Managing Significant Noncompliance or Scientific Fraud / √
REG-008 / Escalation of Noncompliance or Scientific Misconduct / √
REG-009 / Third Party Vendor Inspection and Selection / √
REG-010 / Preparing for and Conducting an Audit of Internal Staff CRAs / √
REG-011 / Protocol Writing / √
SAF-001 / Clinical Study Report / √
TRA-001 / Basic Monitor Requirements and Training / √
TRA-002 / Protocol Specific Monitor Training / √
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Training: Live and on-line training are available to fit your unique training needs. Call for options and pricing.
Customization: Consulting services are available to customize your SOPs to your unique processes. Call for pricing.
Pricing: Includes Microsoft Word electronic format of each SOP with your Organization Name, Address and Logo.
Number of SOPs / Price / Average Price per SOP1 / $ 150 / $150
5 / $ 600 / $120
10 / $ 850 / $ 85
15 / $ 1,100 / $ 73
20 / $ 1,400 / $ 70
25 / $ 1,650 / $ 66
30 / $ 1,900 / $ 63
35 / $ 2,100 / $ 60
Please complete all of the following information which is included in your SOPs, along with your company logo.
Your Name: / Address 1:Email: / Address 2:
Organization: / City:
Phone:
Medical Director: / () - - / State, Zip:
Therapeutic(s):
Payment Preference: Check Credit Card Electronic Company Logo Available? Yes No
SOPs Must Control: Pharmaceuticals Medical Devices Both
Accepted by (Printed Name): Title:
Signature: Date:
Purchase Order or Other Reference Number:
Email Order Form to or mail to address below.
100 Old Cherokee Road, Suite F, PMB 327 Lexington, SC 29072 phone: 803-233-4809 www.nortonaudits.com