Standard operating proceduresthe blueprint of research

Cluj-Napoca, Romania2014 June 17th

Oana M. Pop MACluj School of Public Health

College of Political, Administrative and Communication SciencesBabes-Bolyai University

Standard operating procedures - SOPs

A set of written, detailed instructions or steps needed to perform a specific task the same way each time it is completed

WHEN do we use them?

Every step of the research processInternal organization rules

WHY do we use them?

Identify the person(s) responsible for a specific taskDescribe the steps needed to complete specific actions Train (new)staff/ internsGuideline for conducting research Human protectionData quality

How to write SOPs?

1) Use a template2) Identify the purpose/ aim of the SOP3) Use process mapping (determine each step of the task and try to make it easier to follow)4) Convert the map into rules5) Test the SOP

Process mapping – Clinical research SOP (1)

• Enrollment of subjects in the study

Approach the subject

Apply eligibility criteria

Obtain informed consent

Assign identification code

Process mapping – Clinical research SOP (2)

• Enrollment of subjects in the study

Approach the subject

Apply eligibility criteria

Obtain informed consent

Assign identification code

Prepare study materials

Assess demographic criteria

Describe the study

Type of informed consent form

Respond to questions

Check list of available codes

Assess biologic criteria

Process mapping – internal organization SOP (1)

• Making a cup of coffee (Woodin, 2004)

Ensure coffee maker is ready

Add the coffee

Add the water

Turn on the machine

Serve the coffee

Process mapping – internal organization SOP (2)

• Making a cup of coffee (Woodin, 2004)

Ensure coffee maker is ready

Add the coffee

Add the water

Turn on the machine

Serve the coffee

Ensure the machine is plugged in

Ensure carafe is empty and clean

Place filter in the basket

Measure the coffee

Measure water quantity

Place the carafe in the machine

Wait until the coffee has stopped dripping

The elements of SOPs

1) Headline2) Purpose3) Responsibilities4) Definitions5) Instructions/ procedures6) Materials and equipment7) Attachements8) Revision history

It needs to contain the name of the author, the number of the SOP, issued date, effective date, last updated date, approval

Headline

Header (example)

Standard Operating Procedure Author POM

SOP on how to write a Standard Operating Procedure

SOP # 1

Revision # 1.0

Issued date 17.06.2014

Effective Date 20.06.2014

Last Updated 17.06.2014

Page 1 of # 2 Approval PI

Write down to goal/ aim of the SOP Purpose

Purpose (example)

The aim of this SOP is to describe the process of subjects’ enrollment in the study

State the person (avoid using names; use titles instead) responsible to comply with the SOP and the person responsible for training the personnel

Responsibilities

Responsibilities (example)

Data collectors are responsible for applying this SOP when enrolling subjects in the study. The research assistant will train data collectors in the rules of the SOP.

Define terms and acronyms used in the SOPDefinitions

Definitions (example)

IC = Informed consentBQ-W = Baseline questionnaire for womenBQ-M = Baseline questionnaire for men

Use process mapping to break down the task into steps and further detail the steps. Use clear and concise language.

Instructions/ procedures

Subjects’ enrollment in the study

Approach the subject

Prepare study materials

Describe the study

Instructions (example)

Instructions (example)

1. Approach the subject1.1. The data collector should have a study description, two informed consents, one BQ-W questionnaire and the Eligibility Registry on him, before approaching the subject.1.2. The data collector should approach the subject and describe the study to him, if the subject is interested to participate.

List all of the materials and equipment needed to complete the procedure

Materials and equipment

Materials (example)

The MicroCO device is needed to assess the biological eligibility criterion

List applicable forms that are required to be completed in the SOP

Attachments

Attachments (example)

1. The consent form2. The Eligibility Registry

History of the revisions made on the SOP

Revision history

Revision history (example)

Revision History

Revision Date AuthorChange reference Reason for change

1.0 17.06.2014 POM All pages Template development

… …

1. PurposeWrite down the goal of the SOP (why the SOP is being written). Mention the objective(s) the SOP is intended to achieve

2. ResponsibilitiesState the personnel, departments or groups responsible for both performing and complying with the SOP. State the person responsible for assuring the appropriate personnel are trained in the SOP.

3. DefinitionsDefine terms and acronyms that people reading the SOP would require clarification on.

4. Instructions/ Procedures

Instructions are developed based on the process mapping and should be specified in a clear and concise language. Avoid using passive voice and names (use titles instead). Specify order in which activities are done. If an SOP comprises a long list of steps, break down the steps into logical sections of about 7-10 steps per section. Flowcharts/ diagrams and references to other associated SOPs can also be inserted.

5. Materials and Equipment

List all of the materials and equipment needed to complete the procedure.

6. AttachmentsList applicable forms that are required to be completed in the SOP (such as informed consent forms of questionnaires).