TOOL 1.

3
SOP Management Example

Assign unique SOP identifier number such as : PR-GE-01

INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

Note: This document is meant to serve as an example only as to how an SOP template could be designed and how SOPs could be managed. This
should be adopted to be fit-for-purpose for the survey.

1. Purpose and scope

The purpose of this standard operating procedure (SOP) is to describe how SOPs are developed, reviewed, approved, controlled and
archived using the approved format. This includes distribution and change management of procedures and work instructions. Associated
tools (forms/templates/checklists) are not controlled documents and may be adapted to suit the needs of the particular survey.

2. Definitions

Term Definition

Release date The date the SOP or work instruction is released. Controlled documents become effective within
two weeks of the release date, to allow for distribution and training.

Review date The date at which the SOP must be reviewed to ensure the procedure is still valid and in compliance
with applicable regulations and guidelines. Review date is determined by the process owner and
will vary from one to three years according to the risk of the procedure to the organization.

Purpose and scope A brief description of the reason for the SOP or work instruction and scope to which the process
applies.

Process owner An individual ultimately responsible for the performance of a process and has the ability and au-
thority to make necessary changes.

Responsibilities Description of the activities each functional role is responsible for performing as part of the proce-
dure.

Policy Guidelines that drive the procedures and processes.

Procedure A sequential listing of the steps required to fulfil the purpose and scope of the procedure, for in-
stance, what to do in relation to a process and specifying who is responsible.

Work instruction Describes in detail how to do what is described in an SOP.

Tool A document referenced within an SOP that allows specific actions to be recorded as required in that
SOP. A tool may be a checklist, template, form, etc.

Secure file room A restricted-access room for filing controlled documents as well as essential documents until they
are moved to archive.

1 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys
 Assign unique SOP identifier number such as : PR-GE-01
INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

References Other documents that may be referred to in detail, such as guidelines as well as a list of associated
work instructions or tools.

Document history History of previous versions of the document.

Appendix A flow diagram of the procedure and any additional information that is not included in the proce-
dure itself.

3. Acronyms

Add acronyms as needed, specific to the type of survey; possible acronyms are included below.

GCP Good Clinical Practice

PL Policy (also refers to manual or handbook)

SM Survey Manager

PR Process

SOP Standard Operating Procedure

WI Work Instruction

4. Responsibilities

Define the function (role) and specific activities for which various roles are responsible for this SOP.

Function Activities

Head of xxx / • Determines if an SOP is required

designee • Serves as process owner or delegates this
• Assigns unique controlled document identification number
• Authors, reviews and/or approves controlled documents as needed
• Maintains controlled document master list
• Determines whether controlled documents should be made obsolete

Process owner / • Delegated by [specify role] to initiate development of a new SOP

designee • Manages the lifecycle of the SOP and associated work instructions/Tools
• Measures performance of the process through established key performance indicators
• Authors, reviews and /or approves SOPs as needed; or delegates
• Determines the review cycle and ensures reviews are done within the specified time frame
• Verifies the SOP as written complies with applicable regulations and accurately reflects what is being
done by the responsible party(ies).

SOP author • Drafts SOP in consultation with the intended users

• Circulates SOP for review and approval

2 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys
 Assign unique SOP identifier number such as : PR-GE-01
INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

SOP reviewer • Reviews new and revised SOPs for content coherence and completeness

SOP approver • Verifies that the SOP conforms with current guidelines, standards and applicable regulations
• Approves SOPs

Quality officer • Ensures SOPs/work instructions are developed using the correct format and with proper version
control as described in this procedure
• Files signed original controlled documents (hard copies) in the [specify where] and uploads current
versions to [specify where].
• Tracks distribution of controlled documents and changes to controlled documents, and maintains the
trackers.

5. Procedure

5.1 Controlled document format

All SOPs, work instructions and associated tools (such as checklists and forms) are developed according to the current version of the
templates available on [specify location] These are uploaded by the quality officer/designee. Any individual within [specify organization]
can make a request to [specify role] to originate a new procedure. [Specify role] will determine if an SOP is required and assign a process
owner who assumes responsibility for the lifecycle of the SOP. [Specify role] assigns a unique controlled document identification number
according to document type and updates the controlled document master list as follows:

Standard operating procedures:

• consist of six digits, with alpha-numeric format LL-LL-NN ;

• begin with the code PR (signifying procedure);

• contain a two-letter abbreviation referring to the category of the SOP (e.g. DM=data management; SM=survey management;
GE=general); and

• end with a two-digit unique number.

Work Instruction:

• consist of eight digits, with alpha-numeric format LL-LL-NN-NN;

• begin with the code WI (signifying work instruction);

• contain a two-letter abbreviation referring to the category;

• contain a two-digit number associated with the SOP; and

• end with a two-digit unique number.

5.2 Version control

The first approved version of controlled document will be v1.0. Changes to a controlled document that are considered “minor” such as
spelling corrections, re-wording, or clarifications which do not change the main content of the document are indicated by an increase in

3 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys
 Assign unique SOP identifier number such as : PR-GE-01
INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

the second digit only (e.g. v1.1). Major changes to a document are indicated by an increase in the first digit (such as v2.0). For SOPs, the
version number, release date and review date appear in the header. For work instructions and tools, the footer contains the document
number, version and date.

5.3 Development, review and approval of controlled documents

The SOP lifecycle is illustrated in Appendix 1. [Specify role] serves as the process owner or delegates this to someone who has experience
with the procedure, is knowledgeable about good clinical practice (GCP) as well as applicable regulatory requirements.

The document author will consult with other [specify whom] staff/consultants involved in the process. The SOP Reviewer should have
some knowledge of the procedure and the applicable requirements. Review and approval may be carried out by the same person.

The release date of the SOP refers to the first date that the SOP will be made available to end users. The effective date, two weeks after
release date, is set to allow adequate time for training.

5.3.1 Principles of writing an SOP

• implement an SOP where necessary

• describe the processes so that the deliverables can be achieved with minimal effort

• indicate in the “responsibilities” section who is doing what. Use functions / job title (such as quality officer) instead of individual
names

• make sure all technical terms and acronyms are defined under the section on definitions and acronyms

• keep workflows as logical and simple as possible

• describe the procedures in chronological order

• only include necessary information to perform the procedure and avoid repetitive information

• use concise and simple language

• use active rather than passive language (for instance ‘weigh 10 mg’ rather than ’10 mg should be weighed’)

• use visual aids such as diagrams, flow charts, pictures or tables where possible

• tailor the SOP to the end user

• where precision is needed, avoid phrases such as “do this or alternatively do that”.

5.3.2 Principles for work instructions and tools

Work instructions describe in detail how to perform certain processes within an SOP. The process owner should determine if a work
instruction is needed or not.

It is possible for a work instruction to be developed as a stand-alone document without an associated SOP. Customarily this would be done
for study specific work Instructions that form part of an overall laboratory manual or survey manual.

4 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys
 Assign unique SOP identifier number such as : PR-GE-01
INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

Tools (forms, templates and checklists) enable end users to document the activities they perform associated with an SOP. When possible,
tools should be designed to allow some customization to programme specific requirements (such as TB laboratory assessment questions).
In such cases the process owner is authorized to make such adaptations.

5.4 Distribution

After an SOP/work instruction has been approved, it will be released and distributed to respective users according to job function. The
quality officer distributes the documents along with an accompanying distribution of controlled documents form. External staff and
consultants who are obliged to follow [specify organisation]’s procedures (such as monitors), will receive electronic copies of the SOPs
according to the scope of their work. The quality officer is responsible for tracking distribution and acknowledgement of receipt on the
controlled documents distribution tracker.

5.4.1 Distribution to external parties

Should an external party (such as an external auditor or vendor) request a copy of an internal controlled document, the request must go
through the process owner. The process owner or designee will send the document along with the distribution of controlled documents
form. The receiving client must acknowledge receipt by completing this form and returning it to [specify whom]. The quality officer will
track this.

5.5 Training

Training must be completed before the activity described in the SOP is performed by the individual. Training can be through self-reading,
via video or teleconference and/or a face-to-face as determined by the process owner. The method of training is based on complexity of
procedure, risk to the participants and data integrity, as well as experience level of end users. Documentation of training is required for
major version changes only. Minor changes to an SOP will be communicated to staff members, but does not require documentation of
training. [Refer to applicable training SOPs or manual].

5.6 Review cycle

The process owner determines the review cycle (ranging from one to three years) of an SOP based on the risk of the procedure related to
protection of survey participants, data integrity and the organisation. New SOPs should be reviewed within one year and thereafter every
three years or sooner if significant changes to procedures have been identified (such as implementation of new regulation). Where the
need for modification of an SOP is identified during the work process, anyone involved with that process can bring this to the attention of
the process owner. Feedback will be captured on a controlled document change management tracker, maintained by the quality officer.

The review log follows the SOP for the duration of the SOP lifecycle. For periodic reviews, the date of the actual review should not extend
more than three months after the planned reviewed date.

SOP review log

(To be completed for each review of an approved SOP)

5 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys
 Assign unique SOP identifier number such as : PR-GE-01
INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

SOP version number Review date Revision required Reviewer name (printed)
DD/MMM/YYYY Reviewer signature

S. Smith,
1.0 6 JUL 2020
Yes No

If the PrO reviews an SOP and deems no changes are necessary, the version number and the effective date of the SOP remain unchanged.

If changes are required, the version number and the effective date are revised. Changes to the new version of the SOP will be documented
in document history (section 8 of the SOP). Minor revisions will be detailed in the history. Major revisions to the SOP will be documented
as “extensive changes to the whole text, changing the content of the SOP” in the history and a tracked changes copy in PDF format will be
saved.

5.7 Replacement/discontinuation

The process owner is responsible for controlled document change management as part of process improvement, and will determine if
and when revisions to controlled documents are necessary, such as evaluating compliance with the procedure through internal audit
and change requests. The quality officer will replace the obsolete version by the new version in [specify location] and upload the current
version to [specify where] (so as to avoid staff using the wrong version). The process owner will determine if an SOP should be permanently
discontinued.

Master copies (signed paper originals) of discontinued or replaced SOPs will be archived and no longer accessible to staff members. The
only valid version of controlled documents are filed [specify location]. [specify role] or quality officer is authorized to upload current (valid)
controlled documents/ to [specify where] and remove obsolete documents. These are accessible as read-only to [organization] employees
to view and uncontrolled if printed.

5.8 Archiving

The quality officer maintains signed hard copy originals of controlled documents in the [specify location], which is stored in the designated
secure file room with controlled access until the documents can be moved to a permanent archive. Superseded and discontinued SOPs
are archived for [specify duration].

6. References

• Quality plan

• Controlled document master list (Index)

• SOP template

• Work instruction template

6 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys
 Assign unique SOP identifier number such as : PR-GE-01
INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

7. Appendices

Number Title

1 Process flow diagram/SOP life cycle

8. Document History

Version Changes

1.0 Initial version

9. Review and Approval

Reviewed by: Name and Function Date DDMMMYYYY Signature

Reviewed by: Name and Function Date DDMMMYYYY Signature

10. SOP review log

SOP version number Review date Revision required Reviewer name (printed)
DD/MMM/YYYY Reviewer signature

Yes No

Yes No

7 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys
 Assign unique SOP identifier number such as : PR-GE-01
INSTITUTIONAL LOGO SOP Management

SOP version: Release date: Review date:

Appendix 1: Process Diagram SOP Lifecycle

[SPECIFY ROLE] assigns

process owner and unique
document identifier

Process owner assigns author/reviewer/

approver and initiates development or
revision of document and is responsible for
the SOP lifecycle illustrated below

Review + Periodic Replace /

Draft SOP approve Training review discontinue Archive

OR Replace with
Document new versions
Update document if required remains
effective Discontinue if
no longer
needed

8 Good practices guidance handbook for national TB surveys

How to apply good clinical and good data management practices for national TB surveys