Clinical Research

Standard Operating Procedures (SOPs)

Standard Operating Procedures are the heart of a controlled, well documented and compliant Clinical Research System.  Whether you are a new or established Sponsor, CRO, IRB or Investigator Site, SOPs are a key means of:

• Maximizing Patient Safety                                                  
                                                                                                Investigator
• Minimizing Risk to your Operations                        SOP Order Form
   
• Differentiating from your Competition
   
• Satisfying Protocol and Industry Regulations
   
• Establishing Commitment to Compliant Research with your Customers
   

Please see our free Corrective and Preventative Actions (CAPA) SOP as an example of the proper detail, explanation, law reference, and instruction you will receive from Norton Audits, Inc.  Please review our free CAPA Associated Forms, Logs, Plans and Checklists here .  Lastly, review our Free On-Line CAPA Training as an example of the training that is included with each Investigator SOP.

SOP-Specific On-Line Training Included

Norton Audits SOPs are :                    

• Complimented with  On-Line Training for each Investigator SOP (example)
• Developed, written and maintained by an Experienced Clinical Researcher :
  • Who is an award-winning former FDA Investigator with unique regulation training and knowledge 
  • Who has Direct Clinical Research experience as a Monitor, Consultant, Auditor and Trainer with Clinical Investigators, CROs, Sponsors, and IRBs
• Proven and realistic from our direct experience as Good Clinical Practice Auditors and Consultants to Clinical Investigators, Sponsors, CROs and IRBs
• Specific to Pharmaceuticals, Medical Devices, or both 
• Extensive,following a common template and include:
  • Purpose, Scope and Background Statements
  • Associated FDA Regulations and Policies, GCP and ICH References
  • Detailed Procedure Steps Establishing Responsibilities and Duties of Various Positions
  • Referral to Necessary Forms and Documents that are Completed in Association with the SOP
  • Approval and Revision Tracking Signature Blocks
• Provided in electronic and paper formats with your organization name, address and logo already included
• Usable from the first day after delivery
• Customizable to your particular processes by you or for an additional fee by Norton Audits

For the Clinical Investigator , we offer the following SOPs individually, as a selected group or an entire set.

• Recommended for Investigator Start-Up                         
  • Study Budget Process                                       Investigator

  • Interim Monitoring Visits                               SOP Order Form

  • Writing and Revising SOPs

  • Completion of Form FDA 1572

  • IRB Regulatory Documentation                                       

  • Financial Disclosure by Investigators

  • Documenting Delegation of Authority

  • Responsibilities of Clinical Investigators

  • Investigator Qualification (Pre-Study) Visits

  • Clinical Research Personnel CVs and Licenses

  • Completing and Maintaining Case Report Forms

  • Preparing and Managing Source Data Documentation

  • Obtaining and Documenting Subject Informed Consent

  • Investigator and Clinical Research Team Member Training

• Corrective and Preventative Actions - Included with All Orders

• Recommended for On-Going Investigator Operations

  • Study Close Out Visits

  • Facilitating FDA Inspections

  • Archival of Research Records

  • Advertising for Study Subjects

  • Transporting Hazardous Goods

  • General Correspondence Policy

  • Protocol Feasibility Assessment Plan

  • Investigator On Call or Off Hours Policy

  • Confidentiality of Clinical Trial Information

• Recommended for Advanced Investigator Operations
  • Clinical Research SOP Glossary
  • IRB Continuing Review Submissions
  • Transport of Investigational Products
  • Final IRB Report Review Submission
  • Investigator Initiation Monitoring Visits
  • Protocol Specific Training Requirements
  • Tracking and Reporting Nonconformance
  • Clinical Research Ethical Code of Conduct
  • Investigational Master Drug Accountability
  • Investigational Master Device Accountability
  • Routine Laboratory Equipment Maintenance
  • OSHA Regulations for Blood borne Pathogens
  • Routine Study-Related Equipment Maintenance
  • Final Investigational Master Drug Accountability
  • Final Investigational Master Device Accountability
  • Reporting and Processing Adverse Event or Effects
  • Labeling Requirements for Investigational Products
  • Receipt and Reconciliation of Investigational Products
  • IRB Submission for Protocol Amendments and Revisions
  • Reporting and Processing Serious Adverse Event or Effects
  • Maintaining and Storage of Essential Regulatory Documents
  • Escalation of Significant Noncompliance or Scientific Misconduct
  • Maintaining Investigational Product Blinding Codes and Code Breaking
  • Instructions for the Completion of Common Sponsor-Provided Study Forms 

For the CRO or Monitoring Service Organization , we offer the following SOPs individually, as a selected group or an entire set.  For more information or to Order CRO SOPs please contact us.  Training, including On-Line Training, is not included with CRO/Monitoring SOPs.

• Writing and Revising Standard Operating Procedures

• Basic Monitor Requirements and Training
• Protocol Specific Monitor Training
• Conducting Pre-Qualification Monitoring Visits
• Drug or Device Shipment, Storage and Accountability
• Conducting Study Initiation Monitoring Visits
• Conducting Interim Monitoring Visits
• Monitoring Drug or Device Accountability
• Procedures for Maintaining Patient Source Documentation
• Monitoring Paper Case Report Forms and Source Documents
• Reporting and Processing of Serious Adverse Events or Effects
• Monitoring of Final Drug or Device Accountability
• Final Drug or Device Shipment, Storage and Accountability
• Conducting Close-Out Monitoring Visits
• Clinical Trial Master File
• Preparing for and Conducting an Internal Process Audit
• Preparing for and Conducting an Audit of Study Master Files
• Preparing for and Conducting an Audit of an Investigator’s Site
• Preparing an Audit Report and Subsequent Follow-up
• Preparation Management for Audit by Client or Regulatory Authority
• Handling Reports of Significant Noncompliance or Scientific Fraud
• Escalation of Noncompliance or Scientific Misconduct

For IRBs and Sponsors , we are currently developing SOPs for your operations.  Please contact us for availability.

For more information or to Order CRO SOPs please contact us.