Quality Data...Delivered by Design™

Quality Data...Delivered by Design™



Research Dynamics SOP Templates

All new and updated for 2013!

New SOP on Source Documentation | New appendices added

Full SOP Template Kit: $645.00 + S&H
Individual SOPs: $34.99 + S&H

Fully-Customizable Investigator Site Standard Operating Procedure (SOP) Templates

More comprehensive, with new easy to understand text, sample job descriptions, and attachments.

  • Improve regulatory compliance
  • Enhance staff performance
  • Reduce supervisory and management time
  • Standardize training and research practices

Developing custom SOPs can be time consuming and difficult when starting from scratch. Our 27 SOP templates provide a "quick start" on developing your own custom SOPs. The basic methods are clearly written and ready for your specific procedures to be added.

  • Each SOP is based on both the FDA regulations and ICH guidelines.
  • All SOP template files on CD in Microsoft® Word
Complete SOP Template Kit

Developing custom SOPs can be time consuming and difficult when starting from scratch. Our 26 SOP templates provide a "quick start" on developing your own custom SOPs. The basic methods are clearly written and ready for your specific procedures to be added.

Complete SOP Kit Price: $645 + S&H

Single SOPs

Single SOPs are available for purchase below. View the Table of Contents

Single SOP Price: $34.99 + S&H


General Administration SOPs

GA-01 Standard Operating Procedure for SOPs

GA-02 Investigator Agreements (contracts) with Sponsors/CROs

GA-03 Investigator and Sub-investigator Selection, Qualification, Responsibilities, and Training

GA-04 Coordinator Selection, Qualification, Responsibilities and Training

GA-05 Developing a Plan for Investigator Supervision and Oversight

GA-06 Study Confidentiality

GA-07 Patient Privacy and Confidentiality

GA-08 Disaster Recovery Planning


Clinical Study Conduct SOPs

CO-01 Clinical Study Operations

CO-02 Pre-study Requirements

CO-03 Communication Documentation

CO-04 Regulatory Documentation / Essential documents

CO-05 Protocol Handling, Review of Feasibility, and Approval

CO-06 Institutional Review Board Approval And Operations for Clinical Studies

CO-07 Recruitment Methods

CO-08 Informed Consent

CO-09 Adverse Event Reporting Procedures

CO-10 Sponsor Interactions

CO-11 Handling Clinical Trial Supplies and Investigational Product

CO-12 Study Close-out Activities


Data Management SOPs

DM-01 Source documentation

DM-02 Collection, Recording, and Storage of Clinical Research Data

DM-03 Use of Electronic Data Systems for CRFs and EHR


Quality Assurance / Quality Control SOPs

QA-01 Quality Control

QA-02 Preparing CAPA plans

QA-03 Handling Allegations of Misconduct and Fraud

QA-04 FDA Audits


Appendices
  • Investigator Job Description
  • Coordinator Job Description
  • Study Responsibilities Log
  • Table of ICH Essential Documents
  • Protocol Deviation Log
Upgrades

Upgrades from earlier versions to v.6.0 are available to verified customers who purchased version 4.0 or higher of the Research Dynamics SOP Template Kit for $395.00 + S&H

Contact us at 585-381-1350 x246 for more information.