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Australian Clinical Research Informed Consent Requirements

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					GCP-Clinical Trials Training


   Online Course Catalogue
            2008


                       Australia




           4 Crow Canyon Ct Ste. 200, San Ramon, CA 94583
   Tel : 925.648.1510 | Fax : 925.648.1520 | www.clinfosource.com
           Level 5, 89 Commercial Road, Melbourne, VIC 3004
Tel : 03.9076.8909 | Fax : 03.9076.8940 | www.nucleusnetwork.com.au
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Accreditation:...........................................................................................................................5
Site Personnel Training Program ...........................................................................................5
Course AA. Clinical Trials Training – Core Topics for Site Personnel................................6
Group AA.1. Introduction........................................................................................................................................................ 6
    Topic AA.1.1. Introduction to Clinical Research............................................................................................................6

    Topic AA.1.2. Principles of GCP.......................................................................................................................................6

    Topic AA.1.3. Ethical Considerations in Clinical Research .........................................................................................7

    Topic AA.1.4. Clinical Trials in Australia .......................................................................................................................7

    Topic AA.1.5. Investigator Responsibilities ....................................................................................................................7

    Topic AA.1.6. Phases of Clinical Trials ...........................................................................................................................8
Group AA.2. Informed Consent .............................................................................................................................................. 8
    Topic AA.2.1. Informed Consent -- Elements and Documentation.............................................................................8

    Topic AA.2.2 Informed Consent – Process and Exceptions.........................................................................................8
Group AA.3. Trial Conduct ..................................................................................................................................................... 9
    Topic AA.3.1. Site Selection and Pre-Study Visits ........................................................................................................9

    Topic AA.3.2. Essential Documents in Clinical Research ............................................................................................9

    Topic AA.3.3. Study Drug Accountability.....................................................................................................................10

    Topic AA.3.4. Safety Reporting.......................................................................................................................................10

    Topic AA.3.5. Routine Site Monitoring Visits ..............................................................................................................10

    Topic AA.3.6. Site Audits.................................................................................................................................................11
Course AB: Clinical Trials Training – Advanced Topics for Site Personnel (Part I)
(Available September 2008)...................................................................................................12
Group AB.1. Study Document Development ......................................................................................................................12
    Topic AB.1.1. Protocol Writing .......................................................................................................................................12

    Topic AB.1.2. CRF Design...............................................................................................................................................12
Group AB.2. Site Contract & Budget..................................................................................................................................13
    Topic AB.2.1. Site Contract & Budget...........................................................................................................................13

    Topic AB.2.2. Investigational Site Study Budget.........................................................................................................13
Group AB.3. Ethical Review and Regulatory Applications.............................................................................................14
    Topic AB.3.1. HREC Ethical Review.............................................................................................................................14

    Topic AB.3.2. CTN & CTX Application........................................................................................................................14




ClinfoSource                                                                       2                                                                         2008
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Group AB.4. Additional Topics.............................................................................................................................................14
    Topic AB.4.1. Subject Recruitment & Retention..........................................................................................................14

    Topic AB.4.2. Data Management ....................................................................................................................................15

    Topic AB.4.3. Electronic Records, Electronic Signatures...........................................................................................15
Sponsor/CRO Personnel Training Program ........................................................................16
Course AC. Clinical Trials Training – Core Topics for Sponsor/CRO Personnel (Part I)17
Group AC.1. – Introduction ..................................................................................................................................................17
    Topic AC.1.1. Introduction to Clinical Research..........................................................................................................17

    Topic AC.1.2. Principles of GCP.....................................................................................................................................17

    Topic AC.1.3. Ethical Considerations.............................................................................................................................18

    Topic AC.1.4. Clinical Trials in Australia ......................................................................................................................18
Group AC.2. Trial Preparation............................................................................................................................................18
    Topic AC.2.1. Phases of Clinical trials ...........................................................................................................................18

    Topic AC.2.2. Protocol writing ........................................................................................................................................19

    Topic AC.2.3. CRF Design...............................................................................................................................................19

    Topic AC.2.4. Informed Consent - Elements & Documentation................................................................................20

    Topic AC.2.5. Essential Documents in Clinical Research...........................................................................................20
Group AC.3. Trial Start-up ...................................................................................................................................................20
    Topic AC.3.1. Site Selection.............................................................................................................................................20

    Topic AC.3.2. Monitoring: Pre -study visits ...................................................................................................................21

    Topic AC.3.3. Monitoring: Site Initiation ......................................................................................................................21

    Topic AC.3.4. Informed Consent --- Process & Exceptions.......................................................................................22
Group AC.4. Trial Monitoring..............................................................................................................................................22
    Topic AC.4.1. Routine Site Monitoring..........................................................................................................................22

    Topic AC.4.2. Monitoring: CRF review & SDV ..........................................................................................................22

    Topic AC.4.3. Monitoring: Safety Reporting ................................................................................................................23

    Topic AC.4.4. Monitoring: Drug Accountability..........................................................................................................23

    Topic AC.4.5. Site Close-out............................................................................................................................................24
Course AD. Clinical Trials Training – Advanced Topics for Sponsor/CRO Personnel (Part
I) (Available September 2008)...............................................................................................25
Group AD.1. Roles & Responsibilities................................................................................................................................25
    Topic AD.1.1. Sponsor/Vendor Responsibilities ..........................................................................................................25




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    Topic AD.1.2. Investigator Responsibilities ..................................................................................................................25

    Topic AD.1.3. HREC Ethical Review.............................................................................................................................26
Group AD.2. Drug Discovery and Development...............................................................................................................26
    Topic AD.2.1. Drug Discovery & Development...........................................................................................................26

    Topic AD.2.2. Clinical Trial Design ...............................................................................................................................26
Group AD.3. Regulatory Submissions.................................................................................................................................27
    Topic AD.3.1. CTN & CTX Application .......................................................................................................................27

    Topic AD.3.2. Clinical Study Report (CSR)..................................................................................................................27
Group AD.4. Compliance & Audits.....................................................................................................................................28
    Topic AD.4.1. Clinical Quality Assurance (CQA) .......................................................................................................28

    Topic AD.4.2. SOPs in Clinical .......................................................................................................................................28

    Topic AD.4.3. Sponsor Compliance Audits...................................................................................................................29

    Topic AD.4.4. Site Audit...................................................................................................................................................29
Course AE. Clinical Trials Training – Advanced Topics for Site/Sponsor/CRO Personnel
(Part II) (Available Q4 2008) ................................................................................................30
Group AE.1. Data Management & Biostatistics................................................................................................................30
    Topic AE.1.1. Data Management.....................................................................................................................................30

    Topic AE.1.2. Introduction to Biostatistics....................................................................................................................30

    Topic AE.1.3. Data Analysis & Reporting.....................................................................................................................31
Module AE.2. Project Management.....................................................................................................................................31
    Topic AE.2.1. Project Planning........................................................................................................................................31

    Topic AE.2.2. Integrated Project Management .............................................................................................................32
Module AE.3. Outsourcing....................................................................................................................................................32
    Topic AE.3.1. Vendor Selection ......................................................................................................................................32

    Topic AE.3.2. Vendor Management................................................................................................................................32
Group AE.4. Additional Topics.............................................................................................................................................33
    Topic AE.4.1. Medical Terminology ..............................................................................................................................33

    Topic AE.4.2. IND Application .......................................................................................................................................33

    Topic AE.4.3. NDA Application......................................................................................................................................34




ClinfoSource                                                                      4                                                                        2008
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Accreditation:

   ClinfoSource is approved as an authorized provider by the International
   Association for Continuing Education and Training (IACET). All our topics
   carry IACET continuing education units (CEUs). Please visit IACET web site
   a t w w w . i a c e t . o r g for a list of organizations that accept IACET CEUs.




                    Site Personnel Training Program

   This program consists of core and advanced topics related to Good Clinical
   Practice (GCP), applicable to clinical research from the perspective of the
   investigational site. It is intended to provide the necessary training for
   investigational site personnel such as doctors and nurs e s (INVESTIGATORS
   AND STUDY COORDINATORS) a n d o t h e r s t u d y p e r s o n n e l to better
   understand the regulations regarding clinical research in human subjects,
   and to better understand their own responsibilities in planning and
   conducting clinical trials.




ClinfoSource                               5                                       2008
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Course AA. Clinical Trials Training – Core Topics for Site
Personnel
Group AA.1. Introduction

Topic AA.1.1. Introduction to Clinical Research

Module Content

   •   Provides an overview of the clinical research process including the ethical
       considerations and standards in clinical trials that involve human subjects, key
       elements of clinical trial design, conduct and analysis
   •   The steps involved in the planning, conduct and close-out of clinical trials, and the
       roles and responsibilities of major trial participants
   •   The topics mentioned in this module are discussed in more detail in other modules.

Module Outcome

As a result of completing this module, Users will be able to summarize the clinical research
process including the ethical considerations and standards in clinical trials that involve human
subjects, key elements of clinical trial design, conduct and analysis; the steps involved in the
planning, conduct and close-out of clinical trials, and the roles and responsibilities of major
trial participants.

Topic AA.1.2. Principles of GCP

Module Content

   •   What is meant by good clinical practices or GCP
   •   Regulations governing clinical trials
   •   History of FDA & TGA regulations
   •   International Conference on Harmonisation (ICH)
   •   GCP principles set forth by the ICH

Module Outcome

Upon completing the course, participants will be able to describe the principles of Good
Clinical Practice (GCP), the evolution of United States regulations governing clinical trials,
international guidelines addressing research in humans, and an overview of the
responsibilities of the principal participants in conducting clinical trials.




ClinfoSource                                 6                                       2008
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Topic AA.1.3. Ethical Considerations in Clinical Research

Module Content

   •   Discusses the fundamental ethical considerations in clinical trials that involve human
       subjects
   •   the evolution of human subjects standards
   •   organizations and parties involved with clinical trial ethics
   •   and the responsibilities of different participants. Also examines the ethical
       considerations in trial planning and design, protocol development, and trial conduct.

Module Outcome

As a result of completing this module, Users will be able to discuss the fundamental ethical
principles in clinical research involving human subjects, including the history of their
development, the documents that articulate the m, and the key participants responsible for
carrying them out.

Topic AA.1.4. Clinical Trials in Australia

Module Content

   •   Australian drug development environment
   •   Harmonization of regulations and guidelines in Australia
   •   Processes for conducting Australian clinical trials

Module Outcome

Upon completing this module, students will be able to discuss the current Australian drug
development environment; they will be able to list and describe the processes and regulations
governing clinical trials in Australia.

Topic AA.1.5. Investigator Responsibilities

Module Content

   •   Discusses the responsibilities of the clinical investigator as they apply to the conduct
       of clinical trials, enrolling and ensuring subject’s rights, safety and welfare
   •   the investigator’s responsib ilities towards the HREC and other regulatory bodies
   •   required record keeping and reports
   •   and the expectations at the end of a trial.




ClinfoSource                                 7                                       2008
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Module Outcome

As a result of completing this module, Users will be able to discuss the responsibilities of an
investigator who conducts clinical trials, both with regard to procedural issues and to the
protection of human subjects of research.

Topic AA.1.6. Phases of Clinical Trials

Module Content

   •   This course describes the phases of clinical trials for drugs. Specifically, the
       nomenclature and rationale for each of the four phases of clinical trials. The course
       will review the objectives, nature, and number of subjects or patients participating in
       each phase, and the trial designs and typical endpoints associated with each phase.

Module Outcome

Upon completing this course, Users will be able to list the phases of drug development,
describe the objectives and nature of each phase, and the typical trial designs and endpoints
associated with each phase.

Group AA.2. Informed Consent

Topic AA.2.1. Informed Consent -- Elements and Documentation

Module Content

   •   Discusses the meaning of informed consent and the regulations and guidelines
       governing the protection of human subjects in clinical research. Examines the general
       and specific requirements of informed consent forms, the types of forms that
       document informed consent, and the development of the informed consent form.

Module Outcome

As a result of completing this module, Users will be able to explain the concept of informed
consent, its importance in clinical research, and its regulatory underpinnings.

Topic AA.2.2 Informed Consent – Process and Exceptions

Module Content

   •   Reviews the consent process, responsibilities related to obtaining and documenting
       informed consent, requirements for documenting that proper informed consent was



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       obtained, exceptions to the general requirements, and the consent process in the case
       of research in an emergency situation.

Module Outcome

As a result of completing this module, Users will be able to describe the consent process,
considerations for obtaining consent from vulnerable subjects, consent in pediatric research,
and consent in special situations, including emergency research.

Group AA.3. Trial Conduct

Topic AA.3.1. Site Selection and Pre-Study Visits

Module Content

   •   Discusses the regulations applicable to site selection and pre-study visits. Also reviews
       the purpose of the pre-study visits, their content, and how to prepare for them.

Module Outcome

As a result of completing this module, Users will be able to describe the types of pre-study
visits, their purpose, content, and how to prepare for them.

Topic AA.3.2. Essential Documents in Clinical Research

Module Content

   •   Listing the documents essential to clinical research before, during and at the end of
       clinical trials
   •   Central file set- up
   •   Regulatory audit -- internal and external
   •   Document control
   •   Ethics Submissions
   •   Archiving

Module Outcome

Participants will be able to identify the regulatory documents required in a clinical trial,
description of the document, and how to evaluate if the documents are complete, adequate,
and current. You will also learn the process of creating and maintaining a Trial Master File at
the sponsor/designee, conducting internal audits to ensure the file’s adequacy, and document
control. In addition, you will learn the process of archiving hard copy and electronic
documents during the study and upon study completion. There will also be a brief description



ClinfoSource                                 9                                      2008
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of study files at the investigational site. They will also be able to explain the purpose and
process of archiving the essential documents.

Topic AA.3.3. Study Drug Accountability

Module Content

   •   Discusses accountability standards for investigational products
   •   the regulations and guidelines governing investigational products
   •   and the roles of sponsors, investigators and monitors in insuring the proper use of
       investigational products.

Module Outcome

As a result of completing this module, Users will be able to discuss the responsibilities of the
sponsor and the investigator in the safe and proper handling of study drugs.

Topic AA.3.4. Safety Reporting

Module Content

   •   Focuses on safety reporting during clinical trials of investigational new drugs.
       Reviews the definitions of adverse events (AEs), serious adverse events (SAEs) and
       unexpected adverse events. Discusses the regulations applicable to recording and
       reporting AEs and SAEs
   •   the criteria for reportable SAEs and what is involved in their reporting
   •   the responsibilities of investigators, sponsors and monitors in safety reporting.

Module Outcome

As a result of completing this module, Users will be able to describe adverse events and
serious adverse events, and their reporting requirements.

Topic AA.3.5. Routine Site Monitoring Visits

Module Content

   •   Presents information about routine site monitoring visits by the study sponsor, and the
       applicable regulations. Discusses case report forms and source documents. Explains
       how sites can prepare for routine monitoring visits.




ClinfoSource                                 10                                        2008
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Module Outcome

As a result of completing this module, Users will be able to describe the purpose of routine
monitoring visits, the applicable regulations and guidelines, and how to prepare for these
visits.

Topic AA.3.6. Site Audits

Module Content

   •   Briefly discusses sponsor monitoring visits and sponsor audits of investigational sites.
       The main focus of the module is on FDA inspections. Reviews the reasons and
       purpose of audits, and the steps that investigational sites should take to prepare for
       them. Discusses common findings, reports and actions resulting from FDA
       inspections.

Module Outcome

As a result of completing this module, Users will be able to understand the types of audits
including FDA inspections, understand the purpose of audits/inspections, the process, and
how to prepare for an audit/inspection.




ClinfoSource                                11                                      2008
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Course AB: Clinical Trials Training – Advanced Topics for
Site Personnel (Part I) (Available September 2008)
Group AB.1. Study Document Development

Topic AB.1.1. Protocol Writing

Module Content

   •   Definition
   •   Purpose
   •   Contents
   •   Sections description
   •   Development process
   •   Review and finalization process
   •   Submission and approval
   •   Amendments

Module Outcome

At the end of this course, participants will be able to describe a clinical study protocol
including its components and purpose in the study. Students will be able to put into practice
the development, finalization, and submission process for protocols as well as understand
when amendments are required.

Topic AB.1.2. CRF Design

Module Content

   •   Defining the case report form
   •   Standard pages and study-specific pages
   •   Serious Adverse Event form
   •   CRF completion instructions
   •   CRF as a source document
   •   CRF revisions

Module Outcome

Participants will be able to define a CRF; design a complete, concise, and user friendly form;
and critically evaluate CRF completion instructio ns to ensure they are unambiguous.




ClinfoSource                                12                                      2008
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Group AB.2. Site Contract & Budget

Topic AB.2.1. Site Contract & Budget

Module Content

   •   Types of investigational sites
   •   Types of site contracts
   •   Contract elements and terms
   •   Budget considerations
   •   Finalizing contract and budget
   •   Contract and budget amendments
   •   Special situations

Module Outcome

Participants will be able to describe the elements and processes involved in developing site
contracts and budgets, the considerations for sponsors and site personnel in developing and
entering into contracts with each other, some items which may not be accounted for in study
budgets and the negotiating process before a site contract and budget are finalized.

Topic AB.2.2. Investigational Site Study Budget

Module Content

   •   This module discusses the following: Budget Development. Normal Costs. Hidden
       Costs. Budget Template. Budget Negotiations. Payment Schedules. Payment Tracking

Module Outcome

Participants will be able to develop a site budget for clinical trials; discuss how to financially
analyse a protocol and begin the first stages of drafting a budget; list the different components
to include in the budget and how to calculate study costs. Participants will be able to describe
how the study budget is related to the contract and which elements are key for negotiations.
Participants will be able to discuss payment schedules and how best to track receipt of
payments.




ClinfoSource                                 13                                       2008
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Group AB.3. Ethical Review and Regulatory Applications

Topic AB.3.1. HREC Ethical Review

Module Content

   •   What are HRECs, IRBs and IECs?
   •   Constitution of HREC
   •   Responsibilities of HREC
   •   Regulations governing their responsibilities
   •   IEC/IRB inspection by the FDA

Module Outcome

Participants will be able to describe what an Human Research Ethics Committee (HREC),
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) means, their
constitution and activities and the regulations that govern them, and their specific roles in
research studies in human subjects.

Topic AB.3.2. CTN & CTX Application

Module Content

   •   What is a CTN and CTX
   •   Contents and Format of CTN and CTX submissions
   •   Clinical Hold
   •   System for applying for CTX or CTN in Australia

Module Outcome

Upon completing this module, participants will be able to describe what an CTN and CTX is,
who should submit a CTN and CTX, and what should be the format and contents of a CTN
and CTX. They will be able to describe the procedure for submissions and the various
milestones within the process.

Group AB.4. Additional Topics

Topic AB.4.1. Subject Recruitment & Retention

Module Content

   •   Sources of potential subjects
   •   Motivation and impediments to subject enrolment and retention



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   •   Suggestions for improving recruitment and retention
   •   Role of investigators, sponsors, ethical review committees and regulators.

Module Outcome

Participants will be able to discuss what motivates potential subjects to participate in clinical
trials, what are the hurdles that cause their decision to not enrol at all or to drop out after
enrolment, what can be done to improve subject enrolment and retention.

Topic AB.4.2. Data Management

Module Content
  • Database design
  • Data management plan
  • Data entry
  • CRF tracking and filing
  • Data management file maintenance
  • Diagnostics
  • Data clarification form and data cleanup
  • Database lock
  • Reopening database.

Module Outcome
Participants will be able to describe how data collected at the clinical study site is reviewed,
tracked, tested for errors and omissions, and cleaned. Participants also will be able to explain
the purpose and contents of a data management plan, how and when a file is declared final,
under what circumstances it can be reopened, and the procedures involved in reopening final
file.

Topic AB.4.3. Electronic Records, Electronic Signatures

Module Content

   •   An overview and discussion of 21 CFR 11, the regulation pertaining to electronic
       records, electronic signatures and handwritten signatures executed to electronic
       records.

Module Outcome

Upon completing this module, participants will be able to explain why 21 CFR 11 was
developed, the regulations contained within, and the scope of these regulations. The
discussions and comments received by the FDA, as published in the Federal Register, are
included to provide further insight on the regulations.



ClinfoSource                                 15                                        2008
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                Sponsor/CRO Personnel Training Program

   T h i s p r o g r a m i n c l u d e s c o u r s e s t h a t p r o v i d e c o m pr e h e n s i v e t r a i n i n g o n
   topics related to Good Clinical Practice (GCP) applicable to clinical
   research from the sponsor/CRO perspective. This program is intended
   for personnel (such as CRAs, MONITORS AND OTHERS) at sponsor
   c o m p a n i e s i n t h e b i o p h a r m a c e u t i c a l industry and at contract research
   organizations and other vendors. Completion of this course helps to
   better understand the regulations regarding clinical trials in human
   subjects, and a better understanding of the responsibilities of the
   v a r i o u s p e r s o n n e l in planning and conducting clinical trials.




ClinfoSource                                            16                                                   2008
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Course AC. Clinical Trials Training – Core Topics for
Sponsor/CRO Personnel (Part I)
Group AC.1. – Introduction

Topic AC.1.1. Introduction to Clinical Research

Module Content

   •   Provides an overview of the clinical research process including the ethical
       considerations and standards in clinical trials that involve human subjects, key
       elements of clinical trial design, conduct and analysis
   •   The steps involved in the planning, conduct and close-out of clinical trials, and the
       roles and responsibilities of major trial participants
   •   The topics mentioned in this module are discussed in more detail in other modules.

Module Outcome

As a result of completing this module, Users will be able to summarize the clinical research
process including the ethical considerations and standards in clinical trials that involve human
subjects, key elements of clinical trial design, conduct and analysis; the steps involved in the
planning, conduct and close-out of clinical trials, and the roles and responsibilities of major
trial participants.

Topic AC.1.2. Principles of GCP

Module Content

   •   What is meant by good clinical practices or GCP
   •   Regulations governing clinical trials
   •   History of FDA regulations
   •   International Conference on Harmonisation (ICH)
   •   GCP principles set forth by the ICH

Module Outcome

Upon completing the course, participants will be able to describe the principles of Good
Clinical Practice (GCP), the evolution of United States regulations governing clinical trials,
internatio nal guidelines addressing research in humans, and an overview of the
responsibilities of the principal participants in conducting clinical trials.




ClinfoSource                                17                                       2008
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Topic AC.1.3. Ethical Considerations

Module Content

   •   Discusses the fundamental ethical considerations in clinical trials that involve human
       subjects
   •   the evolution of human subjects standards
   •   organizations and parties involved with clinical trial ethics
   •   and the responsibilities of different participants
   •   Also examines the ethical considerations in trial planning and design, protocol
       development, and trial conduct.

Module Outcome

As a result of completing this module, Users will be able to discuss the fundamental ethical
principles in clinical research involving human subjects, including the history of their
development, the documents that articulate them, and the key participants responsible for
carrying them out.

Topic AC.1.4. Clinical Trials in Australia

Module Content

   •   Australian drug development environment
   •   Harmonization of regulations and guidelines in Australia
   •   Processes for conducting Australian clinical trials

Module Outcome

Upon completing this module, students will be able to discuss the current Australian drug
development environment; they will be able to list and describe the processes and regulations
governing clinical trials in Australia.

Group AC.2. Trial Preparation

Topic AC.2.1. Phases of Clinical trials

Module Content

   •   This course describes the phases of clinical trials for drugs. Specifically, the
       nomenclature and rationale for each of the four phases of clinical trials. The course
       will review the objectives, nature, and number of subjects or patients participating in
       each phase, and the trial designs and typical endpoints associated with each phase.



ClinfoSource                                18                                       2008
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Module Outcome

Upon completing this course, Users will be able to list the phases of drug development,
describe the objectives and nature of each phase, and the typical trial designs and endpoints
associated with each phase.

Topic AC.2.2. Protocol writing

Module Content

   •   Definition
   •   Purpose
   •   Contents
   •   Sections description
   •   Development process
   •   Review and finalization process
   •   Submission and approval
   •   Amendments

Module Outcome

At the end of this course, participants will be able to describe a clinical study protocol
including its components and purpose in the study. Students will be able to put into practice
the development, finalization, and submission process for protocols as well as understand
when amendments are required.

Topic AC.2.3. CRF Design

Module Content

   •   Defining the case report form
   •   Standard pages and study-specific pages
   •   Serious Adverse Event form
   •   CRF completion instructions
   •   CRF as a source document
   •   CRF revisions

Module Outcome

Participants will be able to define a CRF; design a complete, concise, and user friendly form;
and critically evaluate CRF completion instructions to ensure they are unambiguous.




ClinfoSource                                19                                      2008
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Topic AC.2.4. Informed Consent - Elements & Documentation

Module Content

   •   Discusses the meaning of informed consent and the regulations and guidelines
       governing the protection of human subjects in clinical research
   •   Examines the general and specific requirements of informed consent forms, the types
       of forms that document informed consent, and the development of the informed
       consent form.

Module Outcome

As a result of completing this module, Users will be able to explain the concept of informed
consent, its importance in clinical research, and its regulatory underpinnings.

Topic AC.2.5. Essential Documents in Clinical Research

Module Content

   •   Listing the documents essential to clinical research before, during and at the end of
       clinical trials
   •   Central file set- up
   •   Regulatory audit -- internal and external
   •   Document control
   •   Archiving

Module Outcome

Participants will be able to list and describe the documents that are essential in clinical trial
conduct. They will be able to list which documents must be present at the start of the trial,
during the trial and at trial termination. Participants will be able to discuss how central study
file should be set up at sponsor/CRO and study file setup at investigational site. They will also
be able to explain the purpose and process of archiving the essential documents.

Group AC.3. Trial Start-up

Topic AC.3.1. Site Selection

Module Content

   •   Need for site selection
   •   Investigator databases
   •   Impact of selecting inappropriate sites
   •   Site selection criteria


ClinfoSource                                20                                       2008
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    •   Site feasibility questionnaire
    •   Site selection process

Module Outcome

Participants will be able to explain the process of investigator selection (including the
collection and tracking of potential site information), and the importance of investing the time
and effort into selecting investigators appropriate for the study.

Topic AC.3.2. Monitoring: Pre-study visits

Module Content

    •   When to conduct pre-study visits
    •   Site assessment for: Adequacy of resources and facilities, Adequacy of potential
        subject population
    •   Site personnel qualifications review
    •   Site personnel suitability for study participation
    •   Pre-study visit report

Module Outcome

Participants will be able to describe the procedures and requirements of a pre-study visit . In
addition, participants will be able to list the criteria to critically evaluate potential study sites
to determine suitability for study conduct.

Topic AC.3.3. Monitoring: Site Initiation

Module Content

    •   Timing of initiation visit
    •   Items for review: Protocol, CRF, Safety reporting, Investigator responsibilities,
        Regulatory documents and study file
    •   Drug shipment
    •   Accountability and administration procedures
    •   Any other study-specific training
    •   Initiation visit report

Module Outcome

Participants will be able to explain the purpose of, procedures involved in, and proper conduct
of an initiation visit. Participants also will be able to determine the best timing for the visit
and what specific items to review. This course will help prepare both monitors and site
personnel for initiation visits.


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Topic AC.3.4. Informed Consent --- Process & Exceptions

Module Content

   •   Reviews the consent process
   •   responsibilities related to obtaining and documenting informed consent
   •   requirements for documenting that proper informed consent was obtained
   •   exceptions to the general requirements
   •   and the consent process in the case of research in an emergency situation.

Module Outcome

As a result of completing this module, Users will be able to describe the consent process,
considerations for obtaining consent from vulnerable subjects, consent in paediatric research,
and consent in special situations, including emergency research.

Group AC.4. Trial Monitoring

Topic AC.4.1. Routine Site Monitoring

Module Content

   •   Frequency of interim or routine monitoring visits
   •   Preparation for monitoring visits
   •   Routine visit conduct: Review of study status, CRF review, Study file review, Drug
       accountability, Follow-up from previous visits
   •   Visit report and follow- up

Module Outcome

Participants will be able to prepare for routine monitoring visits. Specifically, monitors will be
able to determine the frequency of the visits and the specific activities required at the site visit
-- review CRFs, study files, and study status. Site personnel reviewing this module will be
able to better organize the site for such a visit.

Topic AC.4.2. Monitoring: CRF review & SDV

Module Content

   •   What is a Case Report Form (CRF)
   •   CRF completion instructions
   •   Review of CRFs for completeness and content
   •   Documents that constitute source documents
   •   CRFs as source documents


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   •   Verification of source documents
   •   Subject diaries

Module Outcome

Participants will be able to define CRF and list the documents that can serve as source
documents; participants will be able to systematically review CRFs and verify against source
documents; they will also learn how to handle data discrepancies and corrections.

Topic AC.4.3. Monitoring: Safety Reporting

Module Content

   •   Definition of adverse event (AE)
   •   Definition of serious adverse event (SAE)
   •   Lab abnormalities and toxicity criteria
   •   Reporting requirements for AEs and SAEs
   •   Investigator and sponsor responsibilities
   •   Reporting procedures
   •   SAE reporting forms

Module Outcome

Participants will be able to define adverse and serious adverse events and describe
corresponding reporting requirements. Participants also will be able to describe sponsor and
investigator reporting responsibilities regarding drug safety.

Topic AC.4.4. Monitoring: Drug Accountability

Module Content

   •   Initial drug shipment to investigative site
   •   Drug storage, reconstitution and dispensation at site
   •   Drug return or disposal
   •   Sponsor responsibilities
   •   Monitor responsibilities
   •   Site personnel responsibilities
   •   Controlled substances

Module Outcome

Participants will be able to discuss study drug shipping, storage, and accountability; the
responsibilities of different parties in the proper handling, and the prevention of misuse of



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study drugs; and describe the additional requirements for the proper management of
controlled substances that may be used as study drugs or controls.

Topic AC.4.5. Site Close-out

Module Content

   •   Timing of site close-out
   •   Reasons for close-out
   •   Procedures at site close-out: CRFs, Drug accountability, Other study-related items
   •   HREC notification of study completion
   •   Data clarifications
   •   Review of document retention requirements at site
   •   Site payment
   •   Other items such as publication of results

Module Outcome

Participants will be able to list the situations where a site or study may be closed out.
Participants will be able to define the activities in preparing for and conducting a close-out
visit, and the required follow- up activities.




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Course AD. Clinical Trials Training – Advanced Topics for
Sponsor/CRO Personnel (Part I) (Available September 2008)

Group AD.1. Roles & Responsibilities

Topic AD.1.1. Sponsor/Vendor Responsibilities

Module Content

   •   Sponsor responsibilities in clinical trials -- planning, initiation, implementation,
       reporting
   •   Regulations applicable to sponsor responsibilities
   •   Transfer of responsibilities to vendor
   •

Module Outcome

Participants will be able to explain who clinical trial sponsors are, the specific responsibilities
of clinical trial sponsor as required by regulations, who vendors are and how much of sponsor
responsibilities can be transferred to vendors, such as a contract research organization.

Topic AD.1.2. Investigator Responsibilities

Module Content

   •   Discusses the responsibilities of the clinical investigator as they apply to the conduct
       of clinical trials, enrolling and ensuring subject’s rights, safety and welfare
   •   the investigator’s responsibilities towards the HREC and other regulatory bodies
   •   required record keeping and reports
   •   and the expectations at the end of a trial.

Module Outcome

As a result of completing this module, Users will be able to discuss the responsibilities of an
investigator who conducts clinical trials, both with regard to procedural issues and to the
protection of human subjects of research.




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Topic AD.1.3. HREC Ethical Review

Module Content

   •   What are HRECs, IRBs and IECs?
   •   Constitution of HREC
   •   Responsibilities of HREC
   •   Regulations governing their responsibilities
   •   IEC/IRB inspection by the FDA

Module Outcome

Participants will be able to describe what an Human Research Ethics Committee (HREC),
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) means, their
constitution and activities and the regulations that govern them, and their specific roles in
research studies in human subjects.

Group AD.2. Drug Discovery and Development

Topic AD.2.1. Drug Discovery & Development

Module Content

   •   This modules walks the student through how disease targets are determined, the
       process by which new drugs are discovered, the nonclinical testing processes involved
       before deciding if the entity is 'druggable' and suitable for human trials. It also briefly
       mentions the regulatory processes for transition from nonclinical to clinical testing.

Module Outcome

Upon completing the module, users should be able to list the ways by which new drugs are
discovered, describe how target diseases or conditions are determined, what is involved in
deciding whether a newly discovered entity can proceed to human testing.

Topic AD.2.2. Clinical Trial Design

Module Content

   •   Importance of proper trial design
   •   trial design elements
   •   Discussion of various design elements




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Module Outcome

Upon completing this module, participants will be able to describe the importance of trial
design in the drug development process; they will be able to list and discuss the various
design elements and their pros and cons of their applicability in various trial settings;

Group AD.3. Regulatory Submissions

Topic AD.3.1. CTN & CTX Application

Module Content

   •   What is a CTN and CTX
   •   Contents and Format of CTN and CTX submissions
   •   Clinical Hold
   •   Exemptions to CTN and CTX Requirement
   •   CTN and CTX Reports and Amendments
   •   Withdrawal of CTN and CTX
   •   Termination of CTN and CTX

Module Outcome

Upon completing this module, participants will be able to describe what an CTN and CTX is,
who should submit a CTN and CTX, and what should be the format and contents of a CTN
and CTX. They will be able to list the exemptions to CTN and CTX requirements.
Participants will be able to list and describe the reports and amendments to CTN and CTX
submissions. They can discuss what 'clinical hold' means and in what conditions a part or all
of an CTN and CTX may be placed under clinical hold. Understand what CTN and CTX
withdrawal, suspension, and termination mean, the procedure for such actions and the
outcomes.

Topic AD.3.2. Clinical Study Report (CSR)

Module Content

   •   Definition
   •   Regulations and guidelines
   •   Timing
   •   Contents
   •   Development
   •   Review and finalization process
   •   Submission




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Module Outcome

Upon completion of this course, participants will be able to explain what are clinical study
reports (CSR), specifically, when they are written; who is involved in their development,
review, and finalization; its typical format and components; and its role in the drug approval
application process.

Group AD.4. Compliance & Audits

Topic AD.4.1. Clinical Quality Assurance (CQA)

Module Content

   •   This Module will address the professional discipline of Clinical Quality Assurance
       under the following sections -- CQA Mission & Objectives
   •   CQA – Its origin as an area of professional specialization in clinical trials
   •   Roles & Responsibilities
   •   The CQA culture, Processes & Principles
   •   Approaches to establishing CQA and practical aspects
   •   Audits – Elements of the Audit Skill-Set for CQA

Module Outcome

Participants will be able to describe the deve lopment of CQA as a key component of clinical
development and its role in fostering quality processes; discuss the ways in which CQA can
contribute value to drug development arena; the culture of CQA, the processes and
establishment of the CQA group;

Topic AD.4.2. SOPs in Clinical

Module Content

   •   Definition and purpose of SOPs
   •   Regulations and considerations related to SOPs
   •   SOP development process with mention of typical SOPs found in clinical research
   •   The management and control of the documents
   •   SOP training and compliance.

Module Outcome

Participants will be able to define SOPs, provide insight into the considerations and
procedures for developing SOPs, discuss how to manage and control the SOPs once they are
developed, and describe how to train on and ensure compliance to the procedures described in
the SOPs.


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Topic AD.4.3. Sponsor Compliance Audits

Module Content

   •   GCP requirements for quality
   •   Definition of QA and QC
   •   Standard Operating Procedure (SOP) and Project Plan
   •   Establishing and implementing quality systems
   •   QA and QC plans and procedures applicable to different study tasks
   •   Sponsor’s internal audit
   •   Sponsor audit of vendor
   •   FDA audit of sponsor and vendor

Module Outcome

Prerequisites: Course C, and CTN, CTX or IND, NDA or experience with/understanding of
clinical trial conduct and management. Review of Investigational Site Audits module highly
recommended. Upon completing this module, participants will be able to discuss what QA
and QC mean, how to establish quality systems for various aspects of clinical trials. They will
be able to list some metrics for various study activities; define and discuss internal and
external audits. Participants will be able to explain the findings and possible follow-up actions
following FDA inspections.

Topic AD.4.4. Site Audit

Module Content

   •   Briefly discusses sponsor monitoring visits and sponsor audits of investigational sites
   •   The main focus of the module is on FDA inspections
   •   The relevance of FDA inspections in Australia
   •   Reviews the reasons and purpose of site audits, and the steps that investigational sites
       should take to prepare for them. This is important for monitors and sponsor auditors to
       know in order to prepare the site for a successful FDA inspection
   •   Discusses common findings, reports and actions resulting from FDA inspections.

Module Outcome

As a result of completing this module, Users will be able to understand the types of audits
including FDA inspections, understand the purpose of audits/inspections, the inspection
process, and how to prepare for an audit/inspection.




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Course AE. Clinical Trials Training – Advanced Topics for
Site/Sponsor/CRO Personnel (Part II) (Available Q4 2008)
Group AE.1. Data Management & Biostatistics

Topic AE.1.1. Data Management

Module Content

   •   Database design
   •   Data management plan
   •   Data entry
   •   CRF tracking and filing
   •   Data management file maintenance
   •   Diagnostics
   •   Data clarification form and data cleanup
   •   Database lock
   •   Reopening database.

Module Outcome

Participants will be able to describe how data collected at the clinical study site is reviewed,
tracked, tested for errors and omissions, and cleaned. Participants also will be able to explain
the purpose and contents of a data management plan, how and when a file is declared final,
under what circumstances it can be reopened, and the procedures involved in reopening final
file.

Topic AE.1.2. Introduction to Biostatistics

Module Content

   •   Role of the team statistician in clinical trials
   •   Trial design
   •   Sample size calculation
   •   Type I and II errors
   •   Data analysis and Clinical study report.

Module Outcome
This module provides non-statisticians, entry level statisticians, and medical writers with an
overview of biostatistics. Participants will be able to define the function of biostatistics in
developing a sound study design, in creating a development plan, during the course of the
study, and at study completion. Participants will be able to describe Type I and II errors, and
the role of biostatistics in data analysis and results reporting.


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Topic AE.1.3. Data Analysis & Reporting

Module Content

   •   Report and analysis plan
   •   Goals of interpretation
   •   Approaches to data analysis
   •   Sources of variability
   •   Statistical versus clinical significance
   •   safety data review
   •   Efficacy data review
   •   Handling missing data and deviations
   •   Biostatistics in Clinical Study Report and marketing application.

Module Outcome

Upon completing this module, participants will be able to describe how and when to analyse
clinical trial data and how to consider sources of variability. Users will be able to describe
how to handle data analysis with missing data, protocol deviations etc. Participants will be
able to discuss ethics in data analysis and reporting, integrated summaries of safety and
efficacy as well role of biostatistics in study report and marketing application.

Module AE.2. Project Management

Topic AE.2.1. Project Planning

Module Content

   •   Project definition
   •   Project Management definition and discussion
   •   Personnel resources for a project
   •   Project environment
   •   Processes and planning the scope, schedule and project budget.

Module Outcome

Upon completing this module, participants will be able to discuss what a project means and
what project management is in terms of drug development. Participants will also be able to
list the various stakeholders, and the project-related teams formation, and the responsibilities
of various stakeholders. Participants will be able to identify, plan for and manage the project
scope, schedule and budget. Users will be able to describe what is involved in project plan
development.




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Topic AE.2.2. Integrated Project Management

Module Content
  • Project Communication
  • Project Risk Management
  • Project Integration & Change Control

Module Outcome

By perusing these modules, participants will be able to understand and utilize the tools for
tracking finances, timelines, and resource utilization. They will be able to identify key
indicators and manage variance from projections.

Module AE.3. Outsourcing

Topic AE.3.1. Vendor Selection

Module Content

   •   Study status review meetings and reports
   •   Contract review meetings
   •   Variance analysis
   •   Creating good working relationship
   •   Understanding vendor issues
   •   Management of vendor relations
   •   Post-study review

Module Outcome

Participants will learn practical methods applicable to manage and maintain a productive
relationship between sponsors or vendors, for successful implementation and completion of
outsourced projects.

Topic AE.3.2. Vendor Management

Module Content
  • Vendor types
  • Request for Proposal (RFP) Development
  • Determining potential RFP recipients
  • Internal and vendor communications
  • Proposal receipt and review
  • Evaluation of vendor qualifications
  • Vendor selection and notification



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Module Outcome

Participants will be able to develop selection criteria for potential vendors; manage
communication with potential vendors, RFP distribution, and the proposal review process;
and evaluate and select the most appropriate vendor.

Group AE.4. Additional Topics

Topic AE.4.1. Medical Terminology

Module Content

   •   Origin and formation of medical terms
   •   Common prefixes and suffixes
   •   Root words
   •   Medical abbreviations

Module Outcome

Participants will be able to describe how medical terms are formed and the meaning of
commonly used prefixes and suffixes and root words as they relate to body systems, medical
conditions and treatments.

Topic AE.4.2. IND Application

Module Content

   •   What is an IND
   •   Contents and Format of IND submission
   •   Clinical Hold
   •   Exemptions to IND Requirement
   •   IND Reports and Amendments
   •   Treatment IND and Emergency Use IND
   •   Withdrawal of IND
   •   Termination of IND

Module Outcome

Upon completing this module, participants will be able to describe what an IND is, who
should submit an IND, and what should be the format and contents of an IND. They will be
able to list the exemptions to IND requirement. Participants will be able to list and describe
the reports and amendments to IND submissions. They can discuss what 'clinical hold' means
and in what conditions a part or all of an IND may be placed under clinical hold. Understand



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what IND withdrawal, suspension, and termination mean, the procedure for such actions and
the outcomes.

Topic AE.4.3. NDA Application

Module Content

   •   What is an NDA
   •   When should it be submitted
   •   NDA content and internal review
   •   Abbreviated New Drug Application (ANDA)
   •   Common Technical Document (CTD)
   •   Orphan Drug Act (ODA)
   •   Paediatric Drugs
   •   Drugs for Serious and Life-threatening Conditions
   •   FDA review and actions
   •   Post approval activities, reports

Module Outcome

Prerequisites: Course 12, IND, CSR completion and/or at least one-two years' experience in
clinical trials. Participants will be able to describe what an NDA and ANDA are, and when
they are submitted. They will be able to list the contents of the applications as well as the
development, review and finalization process. Participants will be able to describe the
requirements for special situations such as paediatric drugs and drugs for serious and life-
threatening conditions. Participants will also be able to describe the FDA review process and
actions, as well as post-submission activities and reporting requirements.




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DOCUMENT INFO
Description: Australian Clinical Research Informed Consent Requirements document sample