SOP for preparing SOPs

[Guest guest]

SOP for Preparing SOPs

It is the responsibility of the Chairperson of IEC to constitute an SOP Committee consisting of the member-secretary and two or more members of the IEC who have a thorough understanding of the ethical review process. The SOP writing team carries out the subsequent steps.

• Write down step by step all the procedures of the Ethics Committee for Research on Human Subjects

• Organize, divide and name each process

Design a format and layout

Each SOP should be given a number and a title that is self-explanatory and is easily

understood.

When the need for a new SOP has been identified and agreed upon, a draft is

written by one or more designated members of the SOP team, appointed by the

Chairperson.

If an SOP supersedes a previous version, the previous SOP version should be indicated along with description of the main changes.

Review by Consultation

The draft SOP written by one or more members of the SOP team will be reviewed by the remaining members of the SOP team. After incorporating the suggestions put forth by the SOP team members; a copy of the revised draft SOP is sent to the Member-Secretary, who circulates it to all the IEC members.

Preparation and submission of final draft

IEC members review the revised draft SOP and after incorporating suggestions that are agreed upon by the members the final draft of the SOP is formulated.

The final version is presented to the Chairperson for review and approval.

The authors, reviewers and the Chairperson sign and date the SOP on the first page of the SOP document. This date of approval is declared as the effective date from where by the SOP will be implemented.

When the revised version is distributed, all the IEC members are informed to

destroy the earlier version. One copy of the earlier version is filed centrally in the file entitled ‘Past SOPs of the IEC’ by the Secretariat of the IEC in the IEC office.

The Secretariat should review the SOPs at least once in every 3 years and record the dates of review on the SOP Master file.

Dr. Smita

The INTERNET now has a personality. YOURS! See your Homepage.