Guidance for Use Informational Program for Site
Staff Less Experienced in
Conducting Clinical Research
16 November 2015 v2.0
Program Description
This is an informational program focused on describing the basic concepts of Clinical
Research in accordance with the ICH Guideline for Good Clinical Practice:
Consolidated Guidance (E6).
This program may be used in its entirety or in part:




to supplement the information provided to less experienced Investigators and
their staff by Member companies when starting a Clinical Study.
as on-boarding information for less experienced site staff joining an Investigator
during a Clinical Study.
as a remediation tool in the event of noncompliance during the conduct of a
Clinical Study.
by less experienced Investigators and their staff to demonstrate awareness when
being considered by a TransCelerate member company for participation in a
Clinical Study.
This informational program is available through either:


the TransCelerate Site Qualification and Training website
The Shared Investigator Platform (when available)
Questions regarding this Informational Program may be directed to Theresa Stewart
(Theresa.stewart@actavis.com)
Background
Sponsors are required to select Investigators who are qualified by training and
experience to conduct Clinical Studies. The level of experience may vary amongst
Investigators selected or in some instances less experienced Investigators may not be
selected. Following selection, member companies provide the same study information
to Investigators and their staff regardless of experience level.
This program offers readily available informational topics in key areas of Clinical
Research which can be used as a source of basic information for less experienced
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Guidance for Use Informational Program for Site
Staff Less Experienced in
Conducting Clinical Research
Investigators and their staff. A Completion Certificate is available at the conclusion of
each topic and these certificates may be provided upon request.
Use
Topic Description
This program consists of 11 topics:
Topic Name
What is It?
Value of Use
Clinical Practice vs
Clinical Research –
An overview of the
differences between
the activities which
occur when
managing patients
during routine clinical
practice versus the
activities when you are
managing subjects as
part of a Clinical
Research Study.
Provides a deeper
understanding of
the differences
between Clinical
Practice and
Clinical Research
and what is
involved in
becoming a
Clinical Researcher.
Introduces and
describes the phases
of a Clinical Study and
the various study
designs.
By understanding
the phases and
designs of a study
the Investigator is
able to select the
right study for
his/her site.
Improved
understanding of
Adverse Event
identification and
reporting by
Investigators and
their staff working
directly with study
subjects.
Enhanced subject
Available now on
SQT’s Initiative Assets
page
Clinical Research
Overview –
Available now on
SQT’s Initiative Assets
page
Adverse Events and
Safety – Available
now on SQT’s
Initiative Assets page
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Explains and defines
an Adverse Event.
Describes the
Investigator’s role and
responsibilities
regarding Subject
Safety and reporting
requirements for
Serious Adverse
Events.
Estimated Run
Time
30 minutes
40 minutes
30 minutes
Guidance for Use Informational Program for Site
Staff Less Experienced in
Conducting Clinical Research
Topic Name
Conducting a
Study - Available
now on SQT’s
Initiative Assets page
IRB/IEC
Responsibilities and
Informed Consent Available now on
SQT’s Initiative Assets
page
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What is It?
Value of Use
safety occurs with
the accurate
reporting of
Adverse Events.
Explains the three
Being able to
stages of study
describe and
conduct phases
distinguish the
including the subject
different stages
enrollment/recruitment during the conduct
period, the ongoing
of a study, and the
maintenance and the tasks and activities
subject
associated with
exit/completion phase them, is
including the tasks and instrumental for the
activities associated
successful conduct
with these stages.
of the study as you
can prepare and
plan accordingly. A
successfully
conducted study
helps collect high
quality, reliable
data and ensures
that the rights,
safety, and welfare
of the subjects are
protected.
Overview of the
Prepares the
purpose and activities Investigator and
of the IRB/IEC and the study staff for the
Investigator’s
interactions and
responsibilities in
activities required
accordance with ICH- to obtain approvals
GCP. Describes the
necessary to
process of informed
conduct clinical
consent and the
research studies.
responsibilities of the
Provides the
Investigator when
Investigator and
obtaining informed
staff with the
Estimated Run
Time
30 minutes
30 minutes
Guidance for Use Informational Program for Site
Staff Less Experienced in
Conducting Clinical Research
Topic Name
What is It?
consent.
Delegation and
Training - Available
now on SQT’s
Initiative Assets page
Source
Documentation Available now on
SQT’s Initiative Assets
page
Essential
Documents for a
Clinical Study
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An overview of study
task delegation and
the importance of
providing/documents
study training for site
staff.
A review of the terms
source data and
source documents.
Describes the key
attributes of source
documents, the intent
of ALCOA and CCEA
and describes the
appropriate processes
for creating,
maintaining and
storing source
documents.
Describes the
requirements for
Clinical Study essential
Value of Use
Estimated Run
Time
elements and
requirements
necessary to ensure
that informed
consent will be
obtained and
documented in
accordance with
the ICH-GCP.
Clarifies the
expectations for
20 minutes
Investigator
oversight of the
study. By
delegating tasks to
appropriately
qualified and
trained individuals,
this will enhance
patient safety and
the quality of the
data collected for
a clinical study.
Familiarizes the
Investigator and
20 minutes
site staff with the
expectations and
requirements for
quality
documentation
during clinical trials
to comply with ICHGCP requirements.
Enhanced
regulatory
compliance by
Coming Soon
Guidance for Use Informational Program for Site
Staff Less Experienced in
Conducting Clinical Research
Topic Name
What is It?
Value of Use
documents. Describes
the type of essential
documents collected
for a Clinical Study
during the different
study phases.
Overview of the basics
of Investigational
Product management
and use during a
clinical trial. Topics
include inventory and
temperature control
and
recommendations for
source
documentation.
understanding the
requirements for
preparing and
maintaining
essential
documents.
This topic provides
a guidance for
ensuring quality
handling in every
step of the IP
management
process. The
correct
implementation of
these processes will
ensure the integrity
of the IP and
reducing risk to
subject safety and
data integrity.
Facilities and
Equipment
Describes the
equipment and
resourcing needs of a
research center.
Monitoring and
Auditing
Describes the routine
monitoring and
auditing activities
which occur during a
clinical study. This
topic includes
information on the
purpose, what to
expect, and tips to
prepare for these
Sponsor activities.
Facility, equipment
and trained staff
are all required to
ensure study
success and
patient safety.
By understanding
the purpose and
the routine
activities of
monitoring and
auditing the
Investigator and
study staff will
determine how
they can prepare
and plan for the
Investigational
Product
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Estimated Run
Time
Coming Soon
Coming Soon
Coming Soon
Guidance for Use Informational Program for Site
Staff Less Experienced in
Conducting Clinical Research
Topic Name
What is It?
Value of Use
Estimated Run
Time
time needed when
conducting a
Clinical Study.
Topic Features
All topics share the same navigation features, explained on the second slide within
each topic.
A menu bar in the top right corner features a menu for topic navigation, glossary and
audio notes for the slide.
At the conclusion of each topic, the topic content may be downloaded, including
answers to the Review Questions, by clicking the button labeled ‘Download Topic
Content’ on the ‘Next Steps’ screen. This action exports the content to a PDF which
may be printed or saved for future reference.
Remember, this is an Informational Program and is intended merely to provide
background information and awareness to clinical trial Investigators and clinical trial site
personnel.
Additional requirements may be needed to be in compliance with the Study Protocol
the IRB and the Local Regulatory authority. Consult your Sponsor.
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