Writing Standard Operating Procedures

Standard Operating Procedures are a collaborative team effort

and anyone on the team can write (or help write) one. In some
cases, a research manager or senior coordinator may write SOPs
for the department. In other cases, a coordinator or research as-
sistant may write SOPs for their specific responsibilities, and then
the team collectively edits them into a unified set of documents.
No matter how they get written, the process of creating SOPs can
serve as a tool to anchor site qualification conversations, on-
boarding, and problem troubleshooting.

Getting Started
If you are a new staff member, it is possible that your SOP Drafting Tips
department may not have many SOPs written out. This 1) Start small with drafting a straight-forward
could be for a variety of reasons. Some teams may avoid process and focus on a long-term drafting/im-
drafting SOPs because they feel unnecessarily formal or plementation plan (e.g., 1-2 per week).
prescriptive. While SOPs need to be specific and reflective
of workflow processes, they do not need to read like a le- 2) Delegate SOP drafting responsibilities to
gal contract. Another reason why some avoid SOPs is be- everyone on your team. Provide a template
cause they feel they don’t have time to write them. This is & completed example, so they can see the
especially true in smaller departments and in cases where appropriate format.
one staff member handles a task from beginning-to-end.
3) Align SOP drafting with a time-based goal
Talk to your manager or PI about what documents they like a site initiation visit or onboarding a new
have available to help you as you start performing your staff member.
research responsibilities. It may be helpful for you to
4) Do what is most useful and urgent first, like
write SOPs as you onboard since you are coming in from
a process with multiple stakeholders where
an outside perspective.
everyone needs to be on the same page.
One way to start drafting SOPs is to write out the steps
5) Don’t reinvent the wheel. Someone on your
of a given task as if you were personally explaining it to a
staff likely has emails, to-do lists, or a working
friend, and then ask a colleague if it is clear to them. After
document that can be translated into a SOP.
that, you can add the more formal documentation lan-
guage further outlined in the subsequent sections.

Scope & Purpose

The bulk of your SOP will be specific step-by-step procedures; however, it is important to provide some context by
including a description of the scope and purpose of the SOP. For example, if you are writing an SOP on how to ob-
tain informed consent, your scope and purpose may sound something like this:

The purpose of this SOP is to ensure that the Principal Investigator (PI) and all research team members assist-
ing in the conduct of clinical research are informed about their obligations and responsibilities as they pertain
to Good Clinical Practice (GCP), the investigational plan, applicable regulations, guidance, and institutional
policies. This SOP will apply to all clinical trials research within [Institution name(s)]. This SOP covers the pro-
cesses and procedures that must occur during the informed consent process, which begins with recruitment
and extends through the end of the study, and includes the process of obtaining a signed and dated informed
consent form.
The Basics
While these are primarily internal tools, your SOP may be handed off to a sponsor, monitor, inspector, etc. Be sure
to use consistent font and formatting just as you would in other formal documents that have multiple stakeholders.
Design or choose a template that fits the needs of your team. Some template examples can be found in this guide.
The NU IRB website provides NU-wide SOPs. Be sure your SOP template includes:
◆ SOP title, scope, purpose, and relevant department(s).
◆ Date of initial approval, effective date, and version number (or date). SOPs are a living document that will
evolve with time.
◆ If your department requires SOPs to be reviewed/approved by a particular individual, include an area for their
name, approval date, and possibly their signature/initials.
◆ Keep SOPs together on your shared drive saved as a PDF. Use shortcuts to redirect from other areas of your
shared drive as opposed to saving the document in multiple areas. This prevents staff from using out-of-date
versions.
◆ Use an intuitive file name along with the version date like “SOP – Research Subject Front Desk Check-In (Dec
2021)”. Do not use terms like “updated” or “approved” in file names as there will be future updates and the date
in the file name serves this purpose.

If your SOP involves multiple departments (e.g., lab samples, imaging, etc.), check with the other department(s) on
a template or format before drafting. Ask if they already have a similar SOP with another department that can be
edited to serve your needs.

Language & Usability

The language used in a SOP should be able to be understood by all levels of employees, regardless of whether they
are new to research or have been at your site for years. Remember, the purpose of a SOP is to ensure consistent
outcomes regardless of who is performing the task. Ensure you are writing your SOPs in a way that clearly defines
who (or what role) will be performing each task to help your site staff understand where they fit into the process.
Although some components of a SOP might feel formal (e.g. approval dates, etc.), the bulk of the document should
be usable and intuitive for your staff (and future staff). The following guidelines can help ensure usability:
◆ Use subheadings and text formatting (bold, italics, etc.) in a thoughtful way to highlight important content.
◆ Use bullet points and checkboxes for step-by-step directions.
◆ Identify situations where multiple outcomes for a task may occur (e.g. an abnormal test result during a
follow-up visit) and outline steps for each potential outcome. Inserting a table can help.
◆ Consider adding a flow-chart or graphic to help visualize processes. You can use PowerPoint or Word’s
SmartArt tool to create a custom graphic.
◆ Leverage the talent on your team: Think about staff members who write effective emails or have produced
strong documents/presentations and ask for their help in the SOP writing/editing process.
◆ Ask for feedback from your team before finalizing a SOP. Staff members may interpret things differently or pro-
vide areas for improvement in either the document or the process itself.
◆ Study specific SOPs can be filed as an addendum to a department-wide SOP or filed separately.
◆ Think about past miscommunications or inefficiencies and write the SOP to proactively address similar mis-
takes from happening. Identify your colleagues who are strong communicators and implement some of their
habits (e.g., “I appreciate it when Raul puts the study name and subject number in the email subject line, so I
think we should make that a practice for everyone to do.”)
Maintaining SOPs
SOPs are living documents that evolve over time. They are not a static regulatory document and should be written/
formatted in a way that is useable for everyone on your team. If a SOP is drafted to complete a regulatory or SIV
request and not used regularly, it runs the risk of quickly becoming out-of-date which can present problems during
monitoring visits, inspections, or audits.
In addition to creating SOPs, create a plan to review/update them at least once a year. Some find it helpful to have
this review period aligned with an existing milestone that affects everyone in the department (e.g., Nov/Dec before
the holidays, Apr/Jun before grant submission deadlines, etc.).

SOP Tables, Graphics, & Templates

On the subsequent pages, you will find examples of graphics embedded into a SOP to ensure usability along with
some document templates.
Ideas for Embedded SOP Graphics

This embedded table outlines actions based on multiple outcomes. Note the use of shading and bolded text to draw the eye to
critical content. You can also use tables to outline responsibilities for different individuals on the same task.

If all test results are within normal limits: If there are any abnormal test results:
CRC continues on to Step X CRC completes the items outlined in Step X

AND:

CRC sends an urgent EMR note to the PI with the attached lab
report immediately upon receipt of the results. Include that the
name of the study and subject number in the body of the email. If
the PI does not read or acknowledge the notification within 24
hours, CRC is to contact the practice manager via email.

This graphic supplements SOP text to help staff members visualize the steps of a process and break them down into associated
action-items. Explore Microsoft’s SmartArt to find a template that meets the needs of the process you’re trying to visualize.

• CRC sends imaging report to PI via EMR note. Attach source doc interpretation form
along with subject name/number to the email.
Imaging • Imaging report + CD gets printed by CRC and filed in subject binder.
Completed

• A duplicate CD copy is shipped to the Imaging Core Lab by CRC. See protocol for
shipping information.
• CRC enters tracking information from shipment into EDC.
Shipment • CRC enters duplicate copy of tracking information into eRegulatory Binder.

• Once signed imaging interpretation form is received from PI, the CRC enters data
gets into the EDC within 24 hours.
Data Entry • CRC files original interpretation form in subject binder.

- Templates continue on the next page -

 SOP #
Xxxxxx Department
LOGO Xxxxxx Division/Function Revision #

Implementation Date

Page # 1 of xx Last Reviewed/Update Date

SOP Owner Approval

Standard Operating Procedure

1. Purpose

2. Scope

3. Prerequisites

4. Responsibilities

5. Procedure

6. References

7. Definitions

Documents: SOP short-form

Standard Operating Procedure Template Bizmanualz.com

Document # Title: Print Date:

[ID] [Procedure Name] [Date]
Revision # Prepared By: Date Prepared:
1.0 [Author’s Name] [Date]
Effective Date: Reviewed By: Date Reviewed:
[Date] [Reviewer’s Name] [Date]

Standard: Approved By: Date Approved:

[Standard, Law, [Approver’s Name] [Date]
or Regulation]

Policy:

Purpose:

Scope:

Responsibilities:

Definitions:

Procedure:
1.0 [FIRST PREPARATORY ACTIVITY - PLAN]

2.0 [SECOND ACTIVITY - DO]

3.0 [THIRD ACTIVITY – CHECK]
4.0 [FOURTH ACTIVITY – ACT]
5.0 [USE MORE ACTIVITIES AS NEEDED]
Effectiveness Criteria:
References:

A. [STANDARD, LAW OR REGULATION]

B. [OTHER PROCEDURES, DOCUMENTS, ETC]

Forms/Records:
Satisfies
Form # Record/Form/Activity Name
Clause
Required by Standard
XXXXX Record
Other Forms/Records

[ID] [Procedure Name] [Revision] page 1 of 3

Standard Operating Procedure Template Bizmanualz.com

Satisfies
Form # Record/Form/Activity Name
Clause
XXXXX Record
XXXXX Record
XXXXX Record

Process Map:

[ID] [Procedure Name] [Revision] page 2 of 3

Standard Operating Procedure Template Bizmanualz.com

Revision History:

Revision Date Description of changes Requested By

0.0 [Date] Initial Release

[ID] [Procedure Name] [Revision] page 3 of 3

Standard Operating Procedure Confidential
SOP EFFECTIVE
TITLE:
NUMBER: DATE:
PAGE 1 of 2
Standard Operating
SOP-0102.02
Procedures

APPROVAL BLOCK

APPROVALS TITLE SIGNATURE/DATE

Prepared By:

Reviewed By:

Approved By:

1. PURPOSE

2. SCOPE

3. REPONSIBILITIES

4. REFERENCES

5. BUSINESS REQUIREMENTS

6. PROCEDURE

Responsible Party Action Step

Creation and Routing of an SOP and/or Working
Instruction
1.

2.
3.
4.
Standard Operating Procedure Confidential
SOP EFFECTIVE
TITLE:
NUMBER: DATE:
PAGE 2 of 2
Standard Operating
SOP-0102.02
Procedures

Responsible Party Action Step

5.

6.

7.
8.
Revising and Routing of an SOP and/or
Working Instruction

9.
10.
11.
Approving an SOP and/or Working Instruction

12.
13.
14.
15.

16.
17.

7. DEFINITIONS/ACRONYMS

8. FORMS

VERSION HISTORY

EFFECTIVE
VERSION DESCRIPTION OF CHANGE
DATE