The first and second page
for each SOP contains a
(Insert logo here) title page, a revision log,
and a signatory page.
Standard OperatIng prOcedure
SOP Number: (Insert SOp number here)
Version Number: (Insert Version number here)
Effective Date: (Insert effective date here)
Date of Final Review and Release: (Insert date of Final review and release here)
(If applicable) Version Number this SOP supersedes: (Insert Version number this SOp supersedes)
(If applicable) Date of SOP being superseded: (Insert date of superseded SOp)
HIStOry OF reVISIOnS
Version Number: reason for revision(s)
This SOP (4-GEN) is a
prototypical SOP from the
category. Each SOP is
built on a similar format.
page 1 of 8
Note that each page
contains a common
header and footer (SOP
Name eg, 4-GEN, date,
# of pages) which can be
easily adapted to meet
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Author Title Signature Date
(type author’s first and last (type author’s title here) (author signs here) (author notes data here)
Reviewers Title Signature Date
(type reviewers’ first and (type reviewers’ titles here, (reviewers sign here, and (reviewers write date here,
last names here, and and below. add more rows below) and below)
below. add more rows if if needed.)
Approvals Title Signature Date
(type first and last names (type titles here, and (Sign here, and below) (Write date here, and
here, and below. add more below. add more rows if below)
rows if needed.) needed.)
page 2 of 8
The first part of each
SOP is organized as
(Insert logo here) follows: Purpose, Scope,
Ownership. Please review
the sections below, which
PURPOSE: illustrates the intent of
the purpose of this standard operating procedure (SOp) is two-fold: each section.
(1) to define the responsibilities of, and the actions to be taken by, those responsible for assessing the need for, and for
conducting and documenting the training of those who manage, oversee, and conduct regulated clinical trial research
sponsored by <<InSert company name>>.
(2) to define the responsibilities of those who are required to be trained by <<InSert company name>>.
these policies and procedures apply to <<InSert company name>>, its employees, and subcontractors, including
investigators, staff of contract research Organizations (crOs) involved in a clinical trial, and others who design,
manage, oversee, and conduct regulated research. this training shall include good clinical practices (gcps) and study-
specific information such as the use of the Investigator's Brochure, the protocol, and case report Forms (crFs).
RESPONSIBILITY: Note that the applicable
the director, clinical research or designee who is responsible for the overall management of a clinical trial is company name, eg, XYZ,
should be inserted in the
responsible for ensuring that all those who manage, oversee, and conduct regulated research, sponsored by << InSert
company name>>, are qualified by training and experience to conduct their designated research-related duties. this <<placeholder>>
obligation to ensure personnel working on sponsored research extends to the staff of crOs participating in company-
sponsored research, including investigators and their sites.
Individual department heads within <<InSert company name>> are responsible for identifying those individuals
within their respective departments who require initial and updated training related to assigned research-related
the <<InSert company name>>-designated trainers are responsible for providing initial and continuing training to
all personnel identified by department heads, and to document that training and assess training effectiveness through
appropriate testing strategies.
<<InSert company name>>’s employees are responsible for taking the appropriate training related to their research-
related duties, to demonstrate they can apply that training in conducting their duties, and to document that training as
prescribed in this SOp.
Study Monitors assigned to investigative sites are responsible for ensuring that the investigators and support staff Managerial responsibilites
and others responsible for
are qualified by experience and training to participate in assigned clinical trials. the Study Monitors are specifically
implementing the SOP are
responsible for ensuring that the investigators and supporting staff understand fully the requirements of the clearly stated here. Note
obligations detailed in the Investigator's agreement. that employee “titles”,
departmental org charts
will affect the terminology
OWNERSHIP: that is actually used
the clinical research department owns this SOp. in a customized SOP,
which depends on each
X-name MM-dd-yy and structure.
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The second part of
IDRAC® SOP Library (SAMPLE) each SOP contains
2) Records Management,
4) References, and
• The <<INSERT company name>> designee, who is responsible for the overall management of a clinical trial,
will ensure that:
The Procedures section
is the critical element
of the SOP. Most • Staff assigned by the company or by a CRO to participate in a research project are qualified by training and
have a common pattern experience to conduct their designated research-related duties;
underlying a workflow
process; we have• Individual subcontractors are qualified by training and experience to conduct their designated research-
a consistent approach inrelated duties;
all IDRAC SOPs. Note that
• Department heads identify the training needs of individuals within the respective departments who require
are made about a
common approach, it’s initial and updated training related to assigned research-related duties, and that they in turn ensure that
essential that this section training is completed.
is adapted to describe
a procedure specific to
• Department heads, concerning the individuals who participate in clinical research, ensure that:
a company. By using a
• These individuals are qualified as appropriate, throughout all stages of the trial process, from designing the
you can implement a
wide breadth of SOPS in protocol and crFs and planning the analyses, to analyzing and preparing interim and final clinical Study
a cost-effective manner,reports; and
and conserve internal
resources and time. Those who require training related to assigned research-related duties take the training and prove to the
satisfaction of the assigned trainers that they are appropriately trained.
• The <<INSERT company name>>-designated trainers:
• Schedule, conduct, and document the training of those individuals who have been identified by department
heads as requiring training related to assigned research-related activities.
• Ensure that Study Monitors and others assigned to participate in a clinical trial are appropriately trained, ie,
they have the general scientific and clinical knowledge, and are thoroughly familiar with the investigational
product, the protocol, Informed Consent Form, and any other documents to be provided to subjects, the
Sponsor’s SOps, gcp, and the applicable regulatory requirements.
• Study Monitors, qualified by training and experience to monitor the progress of the investigation, who are
assigned to investigative sites, ensure that:
• The investigators and support staff are qualified by training and experience as appropriate experts to
Note: References to
investigate the drug. (See SOp 12-cLn Investigator Selection and Qualification.) related SOPs are listed in
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• The investigators and supporting staff understand fully their obligations detailed in the Investigator’s
agreement, and the requirements for data collection and reporting to the Institutional review Board/
Independent ethics committee (IrB/Iec) and to <<InSert company name>>. (See SOp 19-cLn
conducting a Site Initiation Visit.)
• The <<INSERT company name>> designee responsible for the overall management of a clinical trial
• Those who handle the data, verify the data, conduct the statistical analyses, and prepare the Clinical Study
reports are appropriately qualified and trained.
• The auditors assigned to audit a clinical trial are qualified by training and experience to conduct audits
properly. an auditor’s qualifications should be documented. (See SOp 14-reg regulatory compliance
audits of clinical Investigational Sites and trial Master Files.)
2.0 RECORDS MANAGEMENT This section clearly
• The assigned trainers perform the following: states the appropriate
• Maintain updated training records for all employees in personnel training files. retention practices.
• Permit regulatory authority review of appropriate training records as evidence that personnel are qualified by
training and experience to conduct their duties.
• Document SOP training.
• Provide copies of certificates of completion of external training programs to the training files.
3.0 DEFINITIONS (Please see Appendix 1: Dictionary Document)
IcH guideline, e6(r1): good clinical practice: consolidated guideline
21 cFr 312.53: Selecting Investigators and Monitors
This section contains
21 cFr 820.25: personnel hyperlinks to source
documents that are
SOp 12-cLn Investigator Selection and Qualification located within IDRAC to
SOp 13-cLn Qualifying, Selecting, contracting, and Monitoring contract research Organizations (crOs) regs, and related SOPs.
SOp 14-reg regulatory compliance audits of clinical Investigational Sites and trial Master Files
SOp 19-cLn conducting a Site Initiation Visit
appendIX 1: dictionary document
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appendIX 1: dIctIOnary dOcuMent
Case Report Form (CRF): 1. a printed, optical, or electronic document designed to record all of the protocol-required
information to be reported to the sponsor for each trial subject. 2. A record of clinical study observations and other
information that a study protocol designates must be completed for each subject. NOTE: In common usage, CRF can
refer to either a crF page, which denotes a group of one or more data items linked together for collection and display,
or a casebook, which includes the entire group of crF pages on which a set of clinical study observations and other
information can be or have been collected, or the information actually collected by completion of such crF pages for a
subject in a clinical study [ICH E6 Glossary]. This section contains
terms, abbreviations, and
Contract Research Organization (CRO): a person or an organization (commercial, academic, or other) contracted by
acronyms used in the SOP
the sponsor to perform one or more of a sponsor’s trial-related duties and functions. [ICH E6 Glossary] text. Standard definitions
are derived from CDISC
Clinical Study Protocol (CSP): A document that describes the objective(s), design, methodology, statistical Clinical Research Glossary
considerations, and organization of a trial. the protocol usually also gives the background and rationale for the trial, v6.0. Note in many
but these could be provided in other protocol-referenced documents. throughout the IcH gcp guideline the term instances a specific source
is included at the end of
protocol refers to protocol and protocol amendments. nOte: present usage can refer to any of three distinct entities:
1) the plan (ie, content) of a protocol, 2) the protocol document, and 3) a series of tests or treatments (as in oncology).
[ICH E6 Glossary]
Clinical Study (Trial) Report: a written description of a study of any therapeutic, prophylactic, or diagnostic agent
conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully
integrated into a single report. nOte: For further information, see the IcH guideline for Structure and content of
Clinical Study Reports. [ICH E6 Glossary]
Clinical Trial: A research investigation involving human subjects that is designed to answer specific questions about
the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug,
treatment, or device). [Modified from ICH E6 Glossary, Directive 2001/20/EC]
Consent Form: document used during the informed consent process that is the basis for explaining to potential
subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE:
the informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures
and schedule, potential risks and benefits, alternatives to participation, etc) and explains an individual’s rights as a
subject. It is designed to begin the informed consent process, which consists of conversations between the subject and
the research team. If the individual then decides to enter the trial, s/he gives her/his official consent by signing the
document. Synonym: Informed consent Form; see also Informed consent.
Good Clinical Practice (GCP): a standard for the design, conduct, performance, monitoring, auditing, recording, analyses,
and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and
that the rights, integrity, and confidentiality of trial subjects are protected. NOTE: For Guidance on Good Clinical Practice
see COMP/ICH/135/95; Declaration of Helsinki; 21 CFR 50, 21 CFR 54, 21 CFR 56, and 21 CFR 312. [ICH]
Independent Ethics Committee (IEC): an independent body (a review board or a committee, institutional, regional,
national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose
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responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and
to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable
opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used
in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function,
operations, and regulatory requirements pertaining to independent ethics committees may differ among countries, but
should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [ICH]
See also Institutional review Board.
Informed Consent: An ongoing process that provides the subject with explanations that will help in making educated
decisions about whether to begin or continue participating in a trial. Informed consent is an ongoing, interactive
process, rather than a one¬time information session. nOte: under 21 cFr 50.20, no informed consent form may
include any “language through which the subject or the representative is made to waive or appear to waive any of the
subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from
liability for negligence.” [ICH] See also Consent Form.
Institutional Review Board (IRB): an independent body constituted of medical, scientific, and non-scientific members,
whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a
trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods
and material to be used in obtaining and documenting informed consent of the trial subjects. Synonyms: Independent
Review Board, Independent Ethics Committee, Committee for the Protection of Human Subjects.
Investigator: 1. a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team
of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal
investigator. 2. the individual “under whose immediate direction the test article is administered or dispensed to, or
used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible
leader of that team.” [1. ICH E6 1.35. 2. from 21 CFR 50.3] See also Principal Investigator.
Investigator Agreement: Fda Form 1572, which specifies the investigator’s obligations.
Investigator’s Brochure: a compilation of the clinical and nonclinical data on the investigational product(s) which is
relevant to the study of the investigational product(s) in human subjects.
Principal Investigator: a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a
team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal
Investigator. See also Subinvestigator.
Protocol: See clinical Study protocol.
Sponsor: an individual, company, institution, or organization that takes responsibility for the initiation, management,
and/or financing of a clinical trial. [1. ICH. 2. 21 CFR 50.3]
Study Protocol: See clinical Study protocol.
Subinvestigator: any individual member of the clinical trial team designated and supervised by the investigator at a
trial site to perform critical trial-related procedures and/or to make important trial-related decisions (eg, associates,
residents, research fellows). [ICH] See also Principal Investigator.
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Note: Each appendix
contains a list of
aBBreVIatIOnS/acrOnyMS acronyms for easy
reference. Each SOP can
CRF case report Form be used as a stand-alone
CRO contract research Organization
CSP clinical Study protocol
FDA u.S. Food and drug administration
GCP good clinical practice
IB Investigator’s Brochure
ICH International conference on Harmonisation
IEC Independent ethics committee
IRB Institutional review Board
SOP Standard Operating procedure
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