Investigational Product Release Sop - PDF

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Investigational Product Release Sop - PDF Powered By Docstoc
					                                                                                                                   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
        teaM traInIng
         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         (If applicable) Date of SOP being superseded:            (Insert date of superseded SOp)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
General Administration
category. Each SOP is
built on a similar format.




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                                       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
                                       your needs.
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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)
 name 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.)
 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.)




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                                                                                                                           The first part of each
                                                                                                                           SOP is organized as
(Insert logo here)                                                                                                         follows: Purpose, Scope,
                                                                                                                           Responsibility, and
                                                                                                                           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>>.

SCOPE:
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
                                                                                                                   appropriate positions
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
duties.

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
                                                                                                                           company’s processes
X-name                                                                                                 MM-dd-yy            and structure.
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                                                                                                                                     The second part of
        IDRAC® SOP Library (SAMPLE)                                                                                                  each SOP contains
                                                                                                                                     1) Procedures,
                                                                                                                                     2) Records Management,
                                                                                                                                     3) Definitions,
                                                                                                                                     4) References, and
        1.0          PROCEDURES
                                                                                                                                     5) Appendices
              •	   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	
                   SOPs
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-
                    followed
a consistent approach inrelated duties;
all IDRAC SOPs. Note that
although assumptions
                   •	 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.
                        such
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
“templated” backbone
                   •	 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
                                                                                                                                     the text



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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	
           ensures that:

           •	    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
                                                                                                                      documentation and
      •	   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)

4.0      REFERENCES
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
                                                                                                                      applicable guidelines,
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


5.0    APPENDICES
appendIX 1: dictionary document



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appendIX 1: dIctIOnary dOcuMent

Terms
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
                                                                                                                        Dictionary document:
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:
                                                                                                                          each definition
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 and
aBBreVIatIOnS/acrOnyMS                                           acronyms for easy
                                                                 reference. Each SOP can
CRF       case report Form                                       be used as a stand-alone
                                                                 reference.
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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Description: Investigational Product Release Sop document sample