1. Provide a written record of the process;
2. Ensure compliance with regulations and guidelines;
3. Ensure quality of data;
4. Facilitate audit and inspections;
5. Assure global acceptance.

1. Provide direction;
2. Ensure consistency of task implementation;
3. Enhance performance;
4. Improve work consistency.

1. Helpful tool for training for tasks in a clinical trial (reduce training time);
2. Build confidence in the team members;
3. Reduce supervisory time / effort;
4. Improve communication;
5. Improve motivation and dedication;
6. SOP development process helps in team building.

1. Make policy statements:

A SOP only describes “how” to do the job. For example the policy would state “The engineering department should keep the maintenance department informed of all design changes”. The SOP would include the steps that personnel from the engineering department would take to inform (along with steps to confirm that they have received the information) the maintenance department.

2. Substitute effective management:

Written instructions which are not followed are meaningless!

3. Contain too much “information”:

Information is likely to change, making the SOPs obsolete. For example, if an SOP contains a list of contact name and telephone numbers, say for SAE notification – names and numbers may change. Instead, the SOP should have “references” to data sources such as directories which are always updated.

4. Be, by themselves, complete training manuals not information sources:

The limitations must be recognized. The SOP cannot explain everything a worker needs to know. A SOP should be standard – that is, it should be useful for many different types of products and situations.

Information has been referenced from – Guidelines for Writing SOPs for Clinical Trials Instruction Manual, 2005.