sop writing

QUAL54111 Standard Operating Procedure AssignmentStandard Operating Procedures (SOPs) are written step-by-step instructions on how to perform
procedures correctly. SOPs ensure that procedures lead to consistent and accurate results to reduce
user errors and achieve high quality data. An SOP should be written by a person who knows the
procedure and, if possible, by the staff that will follow the instructions. The review process should also
involve people outside of the writing process, to ensure that the SOP can be used by persons that are
not familiar with the topic.
Due Sunday October 22, 2023 before 11:59PM
For this assignment, you will reflect on your own background and experience in documentation or lab
work to prepare an SOP for a process performed in a GMP regulated environment. You can select one of
the 21 Code of Federal Regulations listed below to write an SOP:
a) 21CFR 211.84: Testing and approval or rejection of components, drug product containers, and
closures.
–
or –
b) 21CFR 211. 194 Laboratory Records
You can write an SOP to describe the entire process of testing and approving components, drug product
containers, and closures as per 21 CFR211.84 or you may choose one particular section within this
regulation to write the SOP. For example, you can describe the specific procedure to perform sample
collection procedures as per 21 CFR21.84 section (c) steps 1 to 6. Similarly, for 21CFR211.194, you can
write the SOP to describe the requirements for laboratory records or focus on 21CFR211.194 section (a)
steps 1 to 8. While 21 CFR211.84 and 21 CRF211.194 are specifically related to lab activities and tests
performed in a regulated environment in the pharmaceutical industry, you can also write an SOP to
describe procedures based on your previous experience in the cosmetic industry, food industry or health
care/hospital setting as long as the procedures conform to cGMP regulations requirements. Please make
sure that you include the following sections in your SOP: title, purpose, scope, definitions,
responsibilities, procedures, references. I have provided sample SOPs for your reference to help you
prepare your own SOP. I have also provided a word document template which you may use to prepare
your SOP.
***Please refer to the SOP rubric which will be used to evaluate your SOP submissions***
SOP Rubric:
• Purpose: The clear aim of the procedure should be stated [2 marks]
• Scope of the procedure This section should describe the type of study in which the developed
procedures will be applied, and the limitations of the procedure, if applicable. [2 marks]
• Definitions Certain technical items and processes listed in the SOP should be described in this section
[2 marks]
• Responsibilities The responsibilities of the departments, different teams, or individuals associated
with the execution of each activity listed in the procedure are discussed in this section, such as those of
an analyst, research associate, clinical, QA, QC, regulatory manager and directors, if applicable. [2
marks]
• Procedures Followed The procedures to be followed by the staff are discussed in this section,
according to who performs what task, and with detailed description of the task. [4 marks]
• Related References References to other SOPs, regulations, or publications are listed in this section. [2
marks]
• Attachments Any special attachments that may be necessary are listed in this procedure.
• Organization [2 marks]
• Spelling and Grammar [4 marks]
Total: 20 marks
***Worth 20% of your final grade***
Standard Operating Procedure:
Title:
Prepared by:
Signature:
Reviewed by:
Signature:
Approved by:
Signature:
Date:
Date:
Date:
1.0 Purpose/Objectives
2.0 Scope
3.0 Definitions
4.0 References and Related documents
5.0 Appendices/Forms
6.0 Procedures
7.0 Owner Department
8.0 Revision History
Revision: 00
Effective Date:
New
Description of Change
Reason & Justification for
Change
58
DEVELOPMENT OF CLINICAL PROTOCOLS, CASE REPORT FORMS
2. SOP for Reporting Adverse Events in a Clinical Study
Title:
SOP for Reporting Adverse Events in a Clinical Study
Purpose:
The purpose of this document is to define the methods and
activities for adverse event reporting in the clinical studies
conducted by the sponsor.
Scope:
This procedure applies to all adverse events that occur during a
clinical study conducted by the sponsor.
Definitions:
Clinical Affairs (CA)
A department of persons trained and experienced in the conduct
of clinical studies. This group manages and oversees
implementation and the overall progress of the sponsor clinical
study, whether directly or by utilization of consultant(s) and/or
CRO(s).
Copyright © 2009. John Wiley & Sons, Incorporated. All rights reserved.
Clinical Site or Center
Any public or private entity or agency or medical or dental
facility where clinical trials are conducted.
Monitor
A person who has been trained to the investigational
protocol(s), informed consent, instructions for use, applicable
SOPs and regulatory requirements, and who checks and
reports the progress of the clinical study at an investigational
site or other data gathering organization (e.g., core lab or other
study facility). The monitor is designated by the sponsor and
may be an employee, a consultant, or an employee of or
consultant to a Contract Research Organization (CRO)
retained by the sponsor. Throughout this document the person
conducting the assessment/qualification site visit will be referred
to as the “monitor.”
Principal Investigator (PI)
An individual who actually conducts a clinical investigation, and
under whose immediate direction the test article is administered
or dispensed to, or used involving, a patient, or, in the event of an
investigation conducted by a team of individuals, is the
responsible leader of that team.
Subject
May also be referred to as “patient” or “trial subject or
patient.” An individual who participates in a clinical trial,
either as a recipient of an investigational product or as a
control.
Abdel-aleem, Salah M.. Design, Execution, and Management of Medical Device Clinical Trials, John Wiley & Sons, Incorporated,
2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/sheridanc-ebooks/detail.action?docID=456029.
Created from sheridanc-ebooks on 2023-10-09 23:18:02.
CLINICAL STANDARD OPERATING PROCEDURES (SOPs)
59
2. SOP for Reporting Adverse Events in a Clinical Study
Case Report Forms (CRFs)
A printed, optical, or electronic collection instrument designed
for clinical trial data capture.
Adverse Event (AE)
Any undesirable medical event occurring in a research subject,
whether or not the event is considered related to the
investigational device.
Serious Adverse Event (SAE)
An AE that results in death, a life-threatening condition
(even if temporary in nature), hospitalization or prolonged
hospitalization, a permanent impairment of body function or
permanent damage to body structure, congenital anomaly/birth
defect, or necessitates medical or surgical intervention to
preclude permanent impairment of a body function or
permanent damage to a body structure, or represents a serious
medical event.
Anticipated Adverse Event
An AE that is listed in the clinical protocol or other studyrelated document that has been identified as a potential AE
related to the investigational device or procedure being studied.
Copyright © 2009. John Wiley & Sons, Incorporated. All rights reserved.
Unanticipated Adverse Device Effect (UADE)
Any serious adverse effect on health or safety or any lifethreatening problem or death caused by, or associated with, a
device, if that effect, problem or death was not previously
identified in nature, severity, or degree of incidence in the
investigational plan or application or any other unanticipated
serious problem associated with a device that relates to the
rights, safety, or welfare of subjects.
Responsibilities:
1. Clinical Affairs Management is responsible for
interpretation, review, update, and implementation of this
procedure.
2. Clinical Affairs Management is also responsible for the review
of all adverse events case report forms and adverse event
reports to ensure that these events were reported
appropriately and within the time periods designated for
reporting certain adverse events.
3. The Principal Investigator at the study site should report
serious adverse events (SAEs) or unanticipated adverse device
effects (UADE) to the sponsor within the designated time
period described in the procedures section under this SOP.
Abdel-aleem, Salah M.. Design, Execution, and Management of Medical Device Clinical Trials, John Wiley & Sons, Incorporated,
2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/sheridanc-ebooks/detail.action?docID=456029.
Created from sheridanc-ebooks on 2023-10-09 23:18:02.
60
DEVELOPMENT OF CLINICAL PROTOCOLS, CASE REPORT FORMS
2. SOP for Reporting Adverse Events in a Clinical Study
Copyright © 2009. John Wiley & Sons, Incorporated. All rights reserved.
Procedures:
1. Adverse Event Case Report Forms All adverse events must
be recorded in the study adverse event case report forms.
These forms include the following information about an
adverse event:
• Description of the AE, including signs and symptoms of the
AE.
• Whether or not the AE is a serious adverse event (SAE). If
an adverse event is determined to be a SAE, then the
rationale for this determination should be checked.
• Whether the AE is anticipated or not. Anticipated AEs are
listed in the study protocol as AEs which potentially could
occur in the study.
• Unanticipated adverse device effects. These are unexpected
AEs which directly related to the study device.
• Time onset and outcome of AE. This includes recording of
the start date, stop date, or ongoing if the AE is not resolved.
In addition, the outcome of the AE as to whether the event
is resolved, not resolved, or resolved with sequelae, should
be recorded in the AE-CRFs.
• Relation of the AE to the study device. The relation of the
AE to study device as to whether the event is related,
possibly related, unrelated, or unknown, should be recorded
in the AE-CRFs.
• Relation of the AE to the study procedure. The relation of
the AE to study procedures as to whether the event is
related, possibly related, unrelated, or unknown, should be
recorded in the AE-CRFs.
• Adverse event severity. Adverse event severity/intensity
should be classified as to whether the AE is mild, moderate,
or severe.
2. Adverse Events Reporting Time Periods
• Serious adverse events (SAEs) and serious UADE should
be reported to the sponsor within 24 hours after the
investigators are becoming aware of the event (this time
period is determined by the sponsor). A final report of the
SAEs and any serious UADE must be submitted to the
sponsor no later than 10 working days after Investigators
become aware of the event.
• SAEs and the serious UADE should be reported to IRB in
accordance with the institution’s IRB policy.
• If the UADE is judged to present unreasonable risk to subjects,
the sponsor should suspend all studies presenting that risk, as
soon as possible, but at most within 5 days after becoming
aware of this risk. The sponsor must report these findings to
FDA, IRBs, and participating Investigators within 10 working
days.
Abdel-aleem, Salah M.. Design, Execution, and Management of Medical Device Clinical Trials, John Wiley & Sons, Incorporated,
2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/sheridanc-ebooks/detail.action?docID=456029.
Created from sheridanc-ebooks on 2023-10-09 23:18:02.
2. SOP for Reporting Adverse Events in a Clinical Study
References:
1. 21 CFR Part 812 FDA Investigational Device Exemption
2. ICH E6 Guideline for Good Clinical Practice
3. ISO 14155 Clinical Investigations of Medical Devices for
Human Patients
Attachments:
Adverse Event CRF Template
3. Standard Operating Procedure for the Development
of Statistical Analysis Plan (SAP)
Title:
Standard Operating Procedure for Development of Statistical
Analysis Plan
Purpose:
This standard operating procedure (SOP) describes the process
for the development and maintenance of Statistical Analysis Plan
for clinical studies.
Scope:
This SOP is applied to all clinical studies conducted by the sponsor:
IDE feasibility, IDE pivotal and post-market studies. This SOP will
be used as guidance for the sharing of data across participant sites,
and the regulatory community.
Definitions:
The following terms used in this SOP are defined as follow:
Copyright © 2009. John Wiley & Sons, Incorporated. All rights reserved.
Case Report Forms (CRFs)
A printed, optical, or electronic collection instrument designed
for clinical trial data capture.
Clinical Protocol
A study plan on which all clinical trials are based. The plan is
carefully designed to safeguard the health of the participants as
well as answer specific research questions. A protocol describes
what types of people may participate in the trial; the schedule of
tests, procedures, medications, and dosages; and the length of the
study. While in a clinical trial, participants following a protocol
are seen regularly by the research staff to monitor their health
and to determine the safety and effectiveness of their treatment
Clinical Protocol Amendment
Changes to the clinical protocol during the course of the study
Statistical Analysis Plan (SAP)
The Statistical Analysis Plan (SAP) refers to the procedures
followed by the sponsor of the study to define and analyze the
study endpoints, measurements, and also to discuss the basis for
the sample size determination of the study. The detailed SAP
includes a plan for how the data of the study is to be presented
in tables, figures, and listings.
Data Manager
This person is responsible for the entry of the data of a clinical
study into specific database system. This responsibility includes
the final generation of the data of clinical study in the form of
tables, graphs, and charts.
Abdel-aleem, Salah M.. Design, Execution, and Management of Medical Device Clinical Trials, John Wiley & Sons, Incorporated,
2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/sheridanc-ebooks/detail.action?docID=456029.
Created from sheridanc-ebooks on 2023-10-09 23:18:02.
62
DEVELOPMENT OF CLINICAL PROTOCOLS, CASE REPORT FORMS
3. Standard Operating Procedure for the Development
of Statistical Analysis Plan (SAP)
Responsibilities:
Study Statistician is responsible for:
1. Ensuring that the protocol and any amendments cover all
relevant statistical issues clearly and accurately.
2. Reviewing the CRFs to ensure that primary and secondary
endpoints are collected and/or captured appropriately to
satisfy analyses called for in the SAP, where applicable.
3. Working with the clinical data manager to update the study
plan if the SAP changes and if those changes reflect changes to
data collected during the conduct of the clinical research trial.
Clinical Study Team
The entire clinical team involved in the study is responsible for
providing input to the Study Statistician on the protocol and
SAP.
Copyright © 2009. John Wiley & Sons, Incorporated. All rights reserved.
Procedures:
1. The SAP is a clearly defined section within the protocol and
approved prior to the start of clinical research study.
2. The SAP should include the details of the planned statistical
analyses associated with a clinical study. The analyses are
planned to include the desired work product(s) and to be
conducted in a consistent and repeatable manner.
3. The SAP should contain the detailed requirements and
parameters for the reporting results of the clinical research
trial, the format and content of output reports, and the tests to
support the robustness and sensitivity of the analysis
conducted.
4. Recommended checks and specific monitoring procedures
should implemented to ensure and improve the quality of the
plan and the associated data, as well as prevent any study
compromise.
.
5 The SAP should include, at a minimum, for each primary and
secondary endpoint:
• How the outcome will be measured.
• Any transformations on the data likely to be required before
analysis.
• Appropriate statistical tests to be used to analyze the data.
• How missing data will be accounted for in the analyses (both
scientifically and statistically).
• Whether statistical inference will be drawn and whether any
statistical adjustments for multiple comparisons will be
performed.
References:
21 CFR Part 11
Attachments:
Attach any specific SAP documents
Abdel-aleem, Salah M.. Design, Execution, and Management of Medical Device Clinical Trials, John Wiley & Sons, Incorporated,
2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/sheridanc-ebooks/detail.action?docID=456029.
Created from sheridanc-ebooks on 2023-10-09 23:18:02.