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MEMORIAL REGIONAL HOSPITAL
Research Ethics Review Committee Issue No. 003
Standard Operating Procedure
Writing and Revising RERC Standard
Operating Procedures Issue Date
CLMMRH
CLMMRH-RERC.SOP.007
Code

7. Writing and Revising RERC Standard

PAGE
Operating Procedures

7.1 Writing RERC SOPs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 100

7.2 Revising RERC SOPs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 103

Supersedes: 001, 002

Authored by: CLMMRH RERC SOP Team (based on PHREB/FERCAP/DOH template)

Effective Date:

Approved by:
DR. EVELYN R. LACSON - Chairman, CLMMRH RERC

Approved by:
DR. JULIUS M. DRILON - Medical Center Chief

Approval Date:

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Research Ethics Review Committee Issue No. 003
Standard Operating Procedure
Writing and Revising RERC Standard
Operating Procedures Issue Date
CLMMRH
CLMMRH-RERC.SOP.007
Code

7.1 Writing and Revising Standard Operating Procedures

7.1.1 Purpose

To define the process for writing and revising SOPs used by the CLMMRH Research
Ethics Review Committee (RERC).

7.1.2 Scope

This SOP provides instructions on how the CLMMRH RERC Standard Operating
Procedures are prepared, approved and distributed.

7.1.3 Responsibility

a. It is the responsibility of the Chair of CLMMRH RERC to appoint an SOP Team to

formulate or revise the SOPs of the CLMMRH RERC. The Chair designates the
members of the team, initiate approval processing of final version of SOPs, and submit
the SOP to the CLMMRH RERC Chair for final approval.

b. The SOP Team is an ad hoc committee composed of appointed RERC members with
invited resource persons. The team is responsible for reviewing and revising existing
SOPs every 3 years. The ad hoc committee may revise a chapter or section as need
arises. The team must follow existing procedures, format, and coding system of the
hospital when drafting or editing any SOP’s of the hospital, and consults the
Secretariat and Chair about the need for new or revised versions of SOPs. The team
submits SOP drafts to the Chair for approval processing.

c. The Secretariat is responsible for coordinating the writing and revising of SOPs,
maintains current SOPs with a complete SOP list, ensures that all CLMMRH RERC
members have access to the SOPs and are working according to the current version
of the SOPs.

d. CLMMRH RERC members are responsible for reviewing and approving the drafts of
new or revised SOPs in a full board meeting, keep a copy of complete SOPs, and
perform their functions according to current SOPs.

e. The CLMMRH Medical Center Chief is responsible for final approval of all SOPs.

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MEMORIAL REGIONAL HOSPITAL 114
Research Ethics Review Committee Issue No. 003
Standard Operating Procedure
Writing and Revising RERC Standard
Operating Procedures Issue Date
CLMMRH
CLMMRH-RERC.SOP.007
Code

7.1.4 Process Flow/ Steps

NO. ACTIVITY RESPONSIBILITY

1. The
1 chair designates an SOP team Chair

2. Design
1 the format, layout, identifier of SOP SOP Team

3. Write
2 a new SOP and submit to Chair SOP Team

4. Review
3 new SOP in full board meeting RERC members

5. 4 Medical Center Chief

Approve new SOP
6. File/distribute
5 approved SOP Secretariat

7.1.5 Detailed Instructions

1. The Chair designates an SOP team

 The Chair assigns members and non-members, as needed, to be part of the

SOP Team.
 The SOP Team receives an orientation from the Chair regarding duties and
responsibilities.
 The Chair can organize SOP Team workshops to facilitate the drafting of SOPs.

2. The design of the format and layout of an SOP is based on the following guidelines:

 An SOP is written according to the following format:

o Number and version

o Title
o Objectives of the SOP
o Scope which includes description and purpose of the SOP
o A flowchart when necessary
o Detailed instructions
o References

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MEMORIAL REGIONAL HOSPITAL 114
Research Ethics Review Committee Issue No. 003
Standard Operating Procedure
Writing and Revising RERC Standard
Operating Procedures Issue Date
CLMMRH
CLMMRH-RERC.SOP.007
Code

Assign an identifier to the SOP.

CORAZON LOCSIN MONTELIBANO Page No. 1 of 10

MEMORIAL REGIONAL HOSPITAL
Research Ethics Review Committee Issue No. YYY
Standard Operating Procedure
<Title of Procedure>
Issue Date mm/dd/yy
CLMMRH
CLMMRH-RER.SOP.XXX
Code

 Each SOP should be given a number and a title that is self-explanatory and is
easily understood. For the CLMMRHR RERC SOPs, the following format is used:
CLMMRH-RER.SOP.XXX where XXX is a three-digit number corresponding to
the chapter/section in the manual where the SOP is found. The YYY is a three-
digit number identifying the issue number of the SOP which will also correspond
to the number of revisions made, and mm/dd/yy is the dateline to identify the
year when SOP was implemented.

 Thus, the SOP on writing of SOPs is identified as CLMMRH-RER.SOP.001, with

Issue No. 001 and Issue Date of _________________: meaning that the SOP
can be seen in Chapter 1 of the SOP manual, it is the first version (Issue No.
001), with no revisions made and was implemented on____________________

The layout of a typical SOP uses a header with the following elements:

 Institutional seal or logo

 Name of institution
 SOP identifier
 SOP title
 Issue number
 Issue date
 Page number

The SOP is introduced by a cover laid out as a typical SOP page with the following
additional items included:

 Summary content after the title

 Date of the previous version; if not applicable, the date of previous issue is
indicated by “N/A” (not applicable)

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MEMORIAL REGIONAL HOSPITAL 114
Research Ethics Review Committee Issue No. 003
Standard Operating Procedure
Writing and Revising RERC Standard
Operating Procedures Issue Date
CLMMRH
CLMMRH-RERC.SOP.007
Code

 Name of the authors/editors

 Approval information such as approving authorities and offices

3. The SOP Team makes a draft of the SOP based on the design and format detailed
above.

 The SOP Team submits completed draft to the Chair.

 The Chair submits the draft to full board review where RERC members deliberate
on the draft
 Upon full board approval, the Chair submits the approved draft to the Medical
Center Chief for final approval.
 The CLMMRH Medical Center Chief approves the SOP by signing in the
appropriate section in the cover page.
 The approved SOPs will be implemented from the date of approval by the
Medical Center Chief.

4. File and distribute the SOP

 Upon approval of CLMMRH Medical Center Chief, the Secretariat sends a copy
to institutional QMS for filing.
 The Secretariat distributes the printed copy of the approved SOPs to the
CLMMRH RERC members and staff; with an electronic copy published through
the Hospital website.
 The Secretariat retains one complete originally signed SOPs copy.

7.2 Revising Standard Operating Procedures

7.2.1 Process Flow/ Steps

NO. ACTIVITY RESPONSIBILITY

1 Propose to revise an SOP RERC member
A draft will be written by designated member/s of the
2 RERC member/s
RERC

A draft of the revised SOP will be reviewed, discussed

3 RERC members
by the RERC members and approved in a Special Full
Board Meeting
The approved draft version will be reviewed by the
Chair of the RERC/
4 Chair who will submit it to the Medical Center Chief for
Medical Center Chief
final approval.

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MEMORIAL REGIONAL HOSPITAL 114
Research Ethics Review Committee Issue No. 003
Standard Operating Procedure
Writing and Revising RERC Standard
Operating Procedures Issue Date
CLMMRH
CLMMRH-RERC.SOP.007
Code

The approved revised SOP will be implemented from

5 Secretariat
the date of approval by the Medical Center Chief.
File/distribute SOP
6 Secretariat
Include revised SOP in SOP’s manual that is currently
7 used and designate a new version number Secretariat

8 Archive superseded SOP Secretariat

7.2.2 Detailed Instructions

1. A proposal to revise an SOP is made in a Full Board Meeting by RERC members.

As the RERC sees fit, an existing SOP may be revised. A revision should be substantial
(correction of grammatical errors is not considered substantial; a change in the identifier
of an SOP is considered substantial). Minor changes refer to editorial, grammatical, or
administrative changes that have no substantial effect on procedures. Major changes, on
the other hand, are those that have a substantial effect on procedures, definitions,
requirements, and similar considerations.

When an SOP is difficult to understand or does not cover what it should, a revision may
become necessary.

2. When the need for a revision of SOP has been identified and agreed on, a draft will
be written by a designated member/s of the RERC called the SOP team.
 Any member of the board may propose for the revision of the SOPs. Any
proposal for revision must be written and submitted to the board for review,
approval, coding, and inclusion into the document.
 The SOP team drafts the revision, noting that the SOP identifier reflects the
chronological number and date of the revision. If an SOP supersedes a previous
version, indicate the previous SOP version and the main changes in the historical
form.

3. A draft of the revised SOP will be reviewed, discussed by the RERC members and
approved in a Special Full Board meeting.

The proposal is discussed and acted upon through full board review.

4. The approved draft version will be reviewed by the Chair who will submit it to the
Medical Center Chief for final approval.

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MEMORIAL REGIONAL HOSPITAL 114
Research Ethics Review Committee Issue No. 003
Standard Operating Procedure
Writing and Revising RERC Standard
Operating Procedures Issue Date
CLMMRH
CLMMRH-RERC.SOP.007
Code

 The CLMMRH Director approves the revised SOP by signing on the appropriate
section of the cover page.

5. The approved revised SOP will be implemented from the date of approval by the
Medical Center Chief.

6. File and distribute the revised SOP.

 Upon approval of CLMMRH Medical Center Chief, the Secretariat sends a copy
of the revised SOP to QMS for filing.
 The revised SOP is distributed to CLMMRH RERC members, updates the SOPs
manual, and publishes the SOP through the Hospital website.

 The Secretariat maintains an updated SOP's manual in the Hospital, but retains
the original manual in the archives.

 The Secretariat distributes the printed copy of the approved SOPs to the
CLMMRH RERC members and staff; with an electronic copy published through
the Hospital website.

 The Secretariat retains one complete originally signed SOPs copy.

7. Include revised SOP in SOP’s manual that is currently used and designate a new
version number

8. Archive superseded SOP.

 The Secretariat archives the superseded version of the SOP in the historical file
maintained by the CLMMRH RERC.

 Superseded SOPs are clearly marked “superseded" with the year of archiving
stamped in the cover page.

Prepared by Reviewed by Approved by

Dr. Evelyn R. Lacson Dr. Marlon Tabligan Dr. Julius M. Drilon

RERC Chairman Quality Management Representative Medical Center Chief II

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