TIPS FOR DEVELOPING

STANDARD OPERATING PROCEDURES

Standard Operating Procedures (SOPs) are tools that document what you REALLY do in YOUR setting or department. They are a means to standardize procedures so that all personnel are performing the same task in an identical manner.

Regulatory Agencies, Study Sponsors and those that oversee research at the University of Pittsburgh recommend that you have SOPs to define your internal research practice standards. Development of SOPS indicates that you are:

  • Knowledgeable about practice standards
  • Aware of regulations
  • Reliable in performance
  • Accountable for your actions

Standard Operating Procedures may be developed for all types of tasks, i.e., administrative, clinical, laboratory, and quality management. They serve as guidance in the event another individual must assume the duty in the absence of the employee(s) who usually perform the task or to train new staff in the standard procedure.

SOPs should be easy to read, step by step instructions. When writing SOPs, address only one task per SOP. They should be concise and not overly detailed or too wordy. Once the SOPs are developed, they should be periodically reviewed and modified to reflect current practices. You may create your own numbering system according to categories or divisions or whatever system will work in your area of research.

You may format your SOPs in any style that meets your needs and will be most useful for your staff. An example of formatting is as follows:
______

UNIVERSITY OF PITTSBURGH

(Department Name)

Standard Operating Procedure

SOP #

SOP Title:Effective Date:

______

1.Purpose: (“To define the procedures utilized to ……………..(describe the task)”

2. Scope:(“This procedure applies to …….(describe the scope and extent of the task)”

(Optional)

3. Responsibility:(Describe who is responsible for the various aspects of the task)

4. Procedures:(List all procedures in logical order)

5. References:(List sources of regulations or reference where these SOPs were derived,

i.e., policies, procedures, IRB reference manual)

For examples of SOPs for the Education and Compliance Office, please refer to the RCCO website:

Version 2/10/09