clinical trial management - sollers college · study startup is the first step in conducting...

Clinical Trial Management

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100 Menlo Park Suite 550 Edison, N. J. 08837

CLINICAL TRIAL MANAGEMENT PROGRAM


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Introduction The Graduate certificate in Clinical Research program is a highly-selective program for students with a strong background in any Biological-Computer-Mathematics/Statistical-or Regulatory Science area that includes Medicine, Nursing, Dentistry, Pharmacy, Microbiology, Biotechnology, Biochemistry, similar areas. Students with a background in Information Technology, Biostatistics, and other general Commerce and Finance background can also take this as an additional specialty option after some prerequisite training. This course provides training for students to learn how the Clinical Trial Management process works. Students will learn about the development of complete Regulatory activities involved in Creating Documents; and in Planning, Organizing, Monitoring, Recording, Analysis and Reporting of Clinical Trials in Human Beings. The program provides additional opportunities to learn about recent advancements as well as specializations in e-Clinical Technology. The study plan for Clinical Trial Management program involves Study Start up, Study Conduct, and Study Close out steps. Study Startup is the first step in conducting Clinical Trials. Study startup dives into topics to help the learner understand the phases of the Clinical Trial, ICH-GCP guidelines, Study Feasibility and Site Selection. The student learns about the IRB/IEC.; Clinical Trial Budgets and Contracts, Essential documents maintained by the Trial Site and Sponsor, Financial Disclosure Form and Clinical Trial Protocol, Investigator’s Brochure, the Informed Consent Process, and Monitoring. Study Conduct is the next step in the CTM program. Students learn about Site Monitoring Visits which include Remote and Central Risk-Based Monitoring concept. How and why Randomization and Blinding are done during Clinical Trials. Learn about Recruitment, Retention and Compliance of patients in the Trials, Adverse Event and Serious Adverse Event reporting guidelines, Drug Advertisement, HIPAA Regulations, and ICH GCP guidelines to appreciate US FDA Regulations and Medical Devices. Students also learn about FDA Inspections, Fraud, Misconduct and Potential Liability. Students get the overview of ePatient Diary, ePRO, eSource, eConsent, eCRF, eISF, eTMF, EHR, EDC, CTMS and similar newer concepts of Risk based Monitoring. Study Closeout is the last part that is done during Clinical Research Program. Students learn about the study close out functions that involves topics like Site Close Out Visit including both On-Site and Remote activities, Site Summary Analysis is required from the Sites to understand the data acquired. Students will learn to understand the Investigational New Drug/ New drug Application Process and the electronic Common Technical Document, ensuring to make sure the Essential Documents after Study Closeout has been filed and submitted properly. Students will have a unique hands on training opportunity with Clinical Trial Management System, Electronic Data Capture Management System, and Electronic Trial Master File Management System. This will done through real time Case Scenarios, Clinical Tasks and other Site Management activities taught by industry experts.


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The CTM system is used to prioritize Site Management Activities, update Site Staff Information, document Site Visits, generate Visit Tasks/Reports, Regulatory Approval and Investigation Payment. The EDC systems are used to enter and verify the Case Report Forms (CRF), Raise/Answer Queries and Generate EDC reports. Use Trial Master File (TMF) to upload/index documents, use naming conventions and electronically sign the documents before submitting. Students work with document Place Holders, Signature Work Flows, TMF Metrics to successfully perform Site Master File/Trial Master File Reconciliation. Contact Hours: 300 Clock Hours Grading: Letter grade based on assignments and examination:

1) Attendance and participation (10%) 2) Mid Term Quiz/Assignments (30%) 3) Case Studies/Assignments (20%) 4) Final Exam (40%)

Letter grade Total points out of 100 A >90 B+ 85-89 B 80-84 C+ 75-79 C 70-74 F <70

Program Policies: Any student suspected of violating this obligation for any reason during the program will be required to participate in the procedural process, initiated at the instructor level. This may include, but is not limited to, the confiscation of the examination of any individual suspected of violating the policy. Furthermore, no student may bring any unauthorized materials to an exam, including dictionaries and programmable calculators.


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Attendance Policy: Class attendance and participation are essential to student success, and constitute 10 percent of a student's grade. The following attendance guidelines will apply:

1) A student who is missing a cumulative of 15 percent of the class meetings and not keeping up with the program assignments may be dropped at the discretion of the instructor.

2) A student is required to successfully complete the program orientation and actively participate in the program. A student not meeting these requirements may be dropped at the discretion of the instructor.

Faculty: Dr. Durdant Dave (MS, MBBS) Dean: Academics and Training

Dr. Durdant Dave is Dean of the Academics and Training, leads the team of versatile talented and

dedicated industry based instructors for this program at Sollers. He has been an Ophthalmologist-

Principal Investigator- in drugs and devices for more than 20 years. He functioned as Director of

Clinical Research at various university affiliated tertiary care multispecialty hospitals to oversee

Phase I-IV Clinical Trials in various therapeutic areas for many years in India. He has functioned

as Senior CRA and Drug Safety associate for more than 6 years in USA.

Who can apply? The Clinical Research foundational training is geared towards Clinicians (Physicians, Nurses,

Dentists, Pharmacists, etc.) and other health science professionals who are interested in conducting

Clinical Research or collaborating with other Clinician-Scientists who conduct Clinical Research.

This program is also beneficial to Health-Science Students, basic-Science Researchers and other

Health Science Professionals who would like to enhance their skills in patient-oriented research.


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Study plan:

Theme Study plan Topics


Study Start Up Module 1 • Phases of the Clinical Trial • ICH-GCP Guidelines • Study Feasibility/Site Selection

Module 2 • IRB/IEC • Budgets • Contracts

Module 3 • Essential Documents (Prior to Study Start) • Financial Disclosure Form • Clinical Trial Protocol

Module 4 • Investigator Brochure • Informed Consent Process • Monitoring- General introduction to all the

types of visits Study Conduct Module 5 • Site Monitoring Visits (Include Remote/Central

Risk-Based Monitoring Concept) • Randomization/Blinding • Recruitment/Retention/Compliance

Module 6 • Adverse Events/Serious Adverse Events • Drug Advertisement • HIPAA Regulations

Module 7 • Medical Devices • Fraud/Misconduct/Potential Liability

Module 8 • FDA Inspection • Essential Documents (During Study Conduct)

Study Close Out Module 9 • Site Close-Out Visit (On-Site/Remote activities)

• Statistical Analysis Module 10 • Investigational Drug Application

• New Drug Application • eCTD (Common Technical Document)

Module 11 • Essential Documents (After Study Close-Out) • Risk-Based Monitoring

Module 12 • Evidence Based Medicine • Personalized Medicine • Big Data


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Internship (20 weeks) Week 1

• Introduction to Clinical Trials • Phases of the Clinical Trials • ICH/GCP (E6) R2 Guidelines • Study Feasibility Questionnaire • Introduction to CTMS system

Week 2 • Training for CTMS system • Setting up Sites in CTMS system • Setting Site staff in CTMS system • FDA form 1572

Week 3 • Qualification Visit Confirmation Letter

• Raise Issues in CTMS system • Generate Qualification report in

CTMS system • Generate Qualification Follow-up

Letter Week 4 • Site Initiation Visit Confirmation

Letter • Raise Issues in CTMS system • Generate Site Initiation report in

CTMS system • Generate Site Initiation Visit Follow-

Up Letter Week 5 • IRB Approval Letter Initial and

Continuing Review • IRB approval Tracking Tool • Budget Template • Contract Template • Introduction to TMF

Week 6 • Training Modules in TMF • Upload Essential Documents • Sample Financial Disclosure Form • Clinical Trial Protocol Template • Protocol Amendment Tracking Tool

Week 7 • IB Sample Template • Training Modules in TMF • Informed Consent Form Template • Informed Consent Form Tracking

Tool


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• Introduction to Monitoring in CTMS system

Week 8 • Introduction to EDC system • Data Entry into eCRF • Source Data Verification • Raise Queries • Investigational Product Accountability

using IPAL Week 9 • Monitoring Visit Confirmation Letter

• Raise Issues in CTMS system • Generate Monitoring Visit Report • Generate Monitoring Visit Follow-Up

Letter Week 10 • Remote Site Management using

CTMS system • Mock Tele-Conference with Site • Issue Resolution • Generate Remote Site Monitoring

Visit Report Week 11 • Introduction to Global Medical Safety

• AE Data Entry in EDC system • SAE Data Entry in EDC system • Sample SAE Report • SAE Reconciliation

Week 12 • Training Modules in TMF • TMF Metrics • TMF Placeholders • Upload Essential Documents into

TMF Week 13 • Training Modules in CTMS system

• Update Site Staff • Regulatory Document Tracking • Track IRB Approvals • Study Timelines

Week 14 • Introduction to FDA Inspection • FDA.gov Resource • Mock FDA Inspection • Inspection Readiness Tracking using

TMF Week 15 • Introduction to HIPAA

• Sample HIPAA Compliance Form


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• Sample Case Studies for Fraud, Misconduct, and Potential Liability

Week 16 • Generate Site Closeout Confirmation Letter

• IP Accountability and Reconciliation • Sample IP Accountability Log • Temperature Excursion Log • Drug Destruction Form • Generate Site Closeout report using

CTMS system • Generate Site Closeout Follow-Up

Letter Week 17 • Sample IND application

• Sample NDA application • Upload Essential Documents using

TMF • Site Master File-TMF Reconciliation

Week 18 • Site Closeout activities in CTMS system including Site Closeout confirmation letter, Closeout Visit Report, Closeout follow-up letter

• Site Closeout activities in TMF • Site Closeout activities in EDC

system Week 19 • Mock Site Qualification Visit in

CTMS system • Mock Site Initiation Visit in CTMS in

CTMS system Week 20 • Mock Site Monitoring Visit in CTMS

System • Mock Site Closeout Visit in CTMS

system

Hands-on training: • CTMS - Clinical Trial Management system • EDC-Electronic Data Capture Management system • eTMF-Electronic Trial Master File • Case studies and Real Time Scenarios taught by industry experts


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CLINICAL TRIAL MANAGEMENT DETAILED SYLLABUS

Study Start up

Module 1

Phases of the Clinical Trials

I. Scientific Concepts and Research Design A. Basic Terms and Definitions B. Different Phases in Clinical Trials C. Types of Study Design D. Data Collection and Management E. Overview of Regulatory Documentation

1. Initial Regulatory Documentation 2. Submission 3. Regulatory 4. IRB Approval 5. Document Exchange 6. Protocol

a. Objectives b. Purpose c. AE/SAE d. Inclusion/Exclusion Criteria e. CRF completion f. Compliance and Deviation Issues

F. Preparation of Recruitment Materials 1. Where stored and labelled 2. What methods employed

a. Local Paper b. Phone Screen c. Cards d. Brochures e. Flyers

II. Study procedures A. Defines the different phases of development B. Explains research methodology and purpose of assigned protocol


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ICH GCP Guidelines

I. Definitions II. Principals

III. PI and Site staff IV. Recruitment and retention challenges at study and Site level V. Risk mitigation, escalation of issues and corrective action

VI. Training A. Scenarios where privacy and confidentiality compromised

and takes action to mitigate risk. B. Identifies violations, corrective actions C. Misconduct and collect supporting information. D. Suspicions E. Corrective and preventive action plan.

Study Feasibility and Site Selection

I. Type of study that is being conducted II. Location

A. Access B. Security C. Communication

III. Compliance A. Training B. Procurement of relevant study tools. C. Deviations from the protocol, SOPs, and the applicable regulatory

requirements. D. Non-compliance E. Blinding F. Misconduct

At the end of this lecture the student will be able to

▪ Understand the Phases of Clinical Trials, ICH/GCP Guidelines and Study Feasibility and Site Selection

Requirements: Students are required to complete the quizzes in the learning portal to evaluate understanding of the above concepts.


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Module 2

IRB/IEC

I. Organization II. Purpose

III. Types IV. Laws Governing V. Members

A. 1.Compensation B. 2.Role C. 3.Policy

VI. Outreach A. Responsibilities B. Composition C. Operations D. Procedures E. Records

Budgets

I. Preparing a Budget II. Study Costs

III. Site Budget IV. Budget Components V. Overhead Costs

Contracts

I. On-time deliverables II. Visit activities

III. Site staff knowledge and ability A. Storage of Medication B. Handling of Medication C. Dispensing of Medication D. Reviews onSite facilities, records, samples, sample storage, temperature monitoring

and equipment calibration records for compliance. E. Confirms adequate supplies, training and delegation.

IV. Site corrective action V. Type of Study


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VI. Phase of the study VII. Type of blinding if any

VIII. How many patients needed IX. Length of the trial X. Number of persons on the trial


▪ Understand the roles and responsibilities of IRB/IEC, Contracts and Budgets

Requirements: Students are required to complete the quizzes in the learning portal to evaluate understanding of the above concepts

Module 3

Essential Documents (prior to study start)

Following documents overview should be generated and should be on file before the trial formally starts:

I. Investigators Brochure A. Investigational Product

II. Signed Protocols and Amendments A. Investigator and Sponsor Agreement

III. CRF/Source Documents A. Document Informed Consent B. Data management activities C. Insurance Statement D. Signed Agreement between all parties involved E. Data management plan F. Data query resolution G. Electronic data (e.g., electronic health records, electronic case report forms

IV. Communication documentation (e.g., telephone, email) V. Case Report Form

VI. Essential Documentation, subject related and non-subject related (e.g., Past Medical Records, Lab Reports, Protocol, IRB Approvals)

VII. Source Documentation VIII. Informed consent form

IX. Financial Aspects of the Trial X. Important required documentation for the trial


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A. Curriculum Vitae and/or other relevant Documents Evidencing Qualifications of B. Investigator(s)and Sub-Investigator(s) C. Normal Value (s)/Range(s) for Medical/ Laboratory/Technical Procedure(s) and/or

Test(s) Included in the Protocol D. Sample of Label(s) Attached to Investigational Product Container(s) E. Pre-Trial Monitoring Report F. Trial Initiation Monitoring Report

Financial Disclosure Form I. All clinical investigators who conducted covered clinical studies

II. Name of Clinical Study III. 21 CRF Part 54 IV. Financial arrangement entered into between the sponsor of the covered study and the

clinical investigator V. Significant payments from Sponsor

VI. Disclosable financial arrangements and interests

Clinical Trial Protocol

I. Protocol development II. Strategy

III. Protocol submission and approval procedures IV. Local and Federal regulatory documentation V. Study design characteristics

VI. Blinding VII. Type of Study (Crossover)

VIII. Randomization IX. Description of procedures X. Amendment submission and approval procedures

XI. Statistical plan At the end of this lecture the student will be able to

▪ Understand the Essential Documents prior to Study Start, Financial Disclosure Form, and the Clinical Trial Protocol



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Module 4

Investigator Brochure

I. Guidelines of the IB a. Purpose of IB b. Parts of an IB c. Contents of IB

II. Dose, Dose Frequency/interval III. Methods of administration IV. Safety monitoring procedures V. Rational and Features of IB

VI. Clinical management of the study subjects VII. Risk-benefit assessment

VIII. Investigational product IX. Compliance with Sponsors written procedures

Informed Consent Process

I. Meaning and Definition II. Importance of Informed Consent

III. Purpose of Informed Consent A. When can trial start B. Where is Informed consent kept C. Who obtains Informed Consent

Monitoring- General introduction to all the types of visits

I. Definition of Monitoring II. Purpose of Monitoring

III. Selection of Monitors IV. Qualifications of Monitors V. Extent and Nature of Monitoring

VI. Monitoring Responsibilities VII. Monitoring Plan

VIII. Standard Operating Procedures IX. Other written procedures in reference to conducting all types of monitoring visits. X. Receives Guidance and Mentoring to Manage Complex Issues

XI. Extent and Nature of Monitoring


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XII. Monitoring Report


▪ Understand the Investigators Brochure, Informed Consent, Monitoring

Requirements: Students are required to complete the quizzes in the learning portal to evaluate understanding of the above concepts

Study Conduct

Module 5

Site monitoring visits (Include Remote/Central Risk-Based Monitoring Concept)

I. Contract Budget Negotiations and Approval Process II. Monitoring Guidelines/Plan and Tools

III. Monitoring Tools IV. Disposition of unused Study-Related Materials (e.g., CRF at end of study, Destruction

of lab kits) V. Equipment and Supplies (e.g., X-Ray, Computer, Lab Kits) and Storage

VI. Equipment and Supply Storage VII. Pre-Study Site Visit

VIII. Investigator's Meeting IX. Site Initiation X. Monitoring Visit

XI. Close-Out Visit XII. Site Monitoring Visit Log

XIII. Site Signature Log XIV. Delegation Listing XV. Trial Master File (e.g., Site, Sponsor)

XVI. Regulatory Documents XVII. Record Retention

XVIII. Visit Reports (e.g., Initiation, Close-Out) XIX. Final Report XX. Progress Reports

Randomization and Blinding

I. Randomization


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a. What is it b. Reason for doing c. Whom involved d. Continuing in study

II. Blinding a. Types b. Reasons c. Length

III. Procedures a. Protocol b. SOP

IV. Integrity V. Adherence

VI. Un-blinding a. Accidental b. Emergency

Recruitment/Retention/Compliance

I. Project timelines a) Length of the studies b) Strategies c) Plan

II. Subject compliance a) Informed Consent b) Type of Patient (Minor, Adult) c) Subject Visit Logistics

III. Subject Selection a) Inclusion/Exclusion Criteria b) Explanation of Study to Patient

IV. Subject retention a) Explanation of Study Length

V. Subject Discontinuation a) Discontinuance

VI. Clinical Trial Registry


▪ Understand the Site Monitoring Visits, Randomization and Blinding, Recruitment/ Retention/Compliance


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Module 6

AE/SAE reporting guidelines

1. Reporting a) Timeline for reporting b) Where to report

2. Difference a) Informed Consent process b) IRB Approvals for Protocol, ICF, Avertisement, CRF, and Amendments c) Role of Investigator and IRB for

Subject Safety Issues (e.g., Toxicity, Significant Lab Values)

Drug Advertisement

1. Types 2. Reasons 3. Instructions

a) Method employed b) Communication c) Target Audience

HIPAA Regulations

1. What is it? a) Definition b) Parts

2. Role in Clinical Trials a) Code of Federal Regulations b) Application in Clinical Trials

3. Parts of HIPAA a) Breakdown

4. Penalties a) Offenses


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b) Costs 5. Effects on Research

a) Regulatory Boundaries 6. Effects on Clinical Care


▪ Understand the AE/SAE reporting guidelines, Drug Advertisement, HIPAA Regulations Requirements:

Students are required to complete the quizzes in the learning portal to evaluate understanding of the above concepts

Module 7

Medical devices

1. Classification 2. Submission

a) Products and Medical Procedures b) 510K Clearances c) In Vitro Diagnostics d) Combination products

3. Medical device bans 4. Medical device safety

a) Medical Device Reporting and Amendments 5. Standards 6. Safety Communications 7. Transparency 8. Premarket requirements 9. Post-market requirements 10. Importing and Exporting devices 11. Recalls

Fraud/misconduct, Potential liability


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I. Types II. Audits

III. Standard Codes IV. Breach of trust V. Extent

VI. Protocols VII. Risk

a) Can fraud be picked up early? b) Impact of fraud

VIII. Research misconduct a) What other countries doing to combat fraud b) Prevention

IX. Building the culture of Research


▪ Understand the Medical Devices, Fraud/misconduct, Potential liability Requirements:

Students are required to complete the quizzes in the learning portal to evaluate understanding of the above concepts.

Module 8

FDA inspection

I. Inspection a) Which Sites trigger and inspection b) Which Sites not evaluated for inspection

I. Pre-Inspection Approval II. Data Integrity Audit

III. Failure to report data IV. Nonconformance

Essential Documents (During study conduct)

Overview of the documents required during study conduct


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I. Filing essential documents at the investigator/Institution level and sponsor Sites II. Auditing of documents

III. Trial master files maintained at the Investigator/Institution Site IV. Investigators Brochure Updates V. Informed Consent

VI. Advertisement for subject recruitment VII. Dated documented approval opinion of IRB

VIII. Protocol amendments IX. Curriculum vitae X. Certificates of analysis

XI. Monitoring visit reports XII. Source documents

a. Subject screening log b. Subject identification code list c. Subject enrollment log d. Signature sheet


▪ Understand the FDA Inspection, Essential Documents (During the Study) Requirements:



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Study Close-Out

Module 9

Site close-out visit (On-Site/Remote activities)

I. Site monitoring visit log II. Site signature log

III. Delegation listing IV. Trial master file (e.g., Site, sponsor) V. Regulatory documents

VI. Record retention VII. Visit reports (e.g., initiation, close-out)

VIII. Final report IX. Progress reports

Site Performance

I. Data Analytics II. Nature of data to be analyzed

III. Relation of the data to be analyzed IV. Relation of the data to underlying population V. Create a model of how the data relates to the underlying population

VI. Prove the validity of the model VII. Employ predictive analytics

VIII. Unstructured and Semi-Structured data


Understand the Site Closeout(On-Site, Remote), and Site Performance Requirements:



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Module 10

IND/NDA application process I. What is IND/NDA

a) When is IND submitted b) When is NDA submitted

II. What is ANDA III. Over-the counter drugs IV. Biologic License Application V. Different forms to be submitted

eCTD (Common Technical Document)

I. Where is CTF used II. Clinical and Nonclinical overview

III. Non-clinical study reports IV. Where is it maintained V. Quality Pharmaceutical documents

VI. Preclinical (Pharmacology/Toxicology VII. Clinical – Efficacy in Clinical Trials


Understand the IND/NDA Application Process, eCTD Requirements:


Module 11


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Essential Documents (After study close-out)

Overview of essential documents after study close-out:

I. Close-out visit II. Site monitoring visit log

III. Site signature log IV. Delegation listing V. Trial master file (e.g., Site, sponsor)

VI. Regulatory documents VII. Record retention

VIII. Visit reports (e.g., initiation, close-out) IX. Final report X. Progress reports

Risk-Based Monitoring

I. Identify Critical Data and Processes to be Monitored II. informed consent

III. Adherence to protocol eligibility criteria IV. study endpoints- Types V. protocol-required safety assessments

VI. evaluating, documenting, and reporting serious adverse events and unanticipated adverse device effects

VII. subject deaths, and withdrawals, especially when a withdrawal may be related to an adverse event

VIII. Conduct and documentation of procedures IX. Risk Assessment X. Complexity of the study design

XI. Electronic Data Capture XII. Monitoring Plan


Understand the Essential Documents (After Study Closeout), and Risk Based Monitoring Requirements:



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Module 12

Evidence Based Medicine

I. Meta-analysis i. Advantages/Disadvantages

ii. Bias A. Types B. Confounding C. External validity/ generalizability

D. Steps E. Studies F. Variables

II.Intervention A. Quantitative aspects of diagnosis and treatment B. Effect Size C. Precision D. Clinical importance of results E. Evaluation of performance F. Quality of Evidence

Personalized Medicine

I. What is it a. Reasons b. How it is Beneficial

II. Methods a. Testing done b. Types of Studies

III. Disease risk assessment a. Types of Risk b. Vulnerable populations

IV. Pharmacogenomics a. Drug Development and Usage b. Challenges c. Regulatory Oversight d. Intellectual Property Rights


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e. Patient Privacy and Confidentiality V. Benefit

a. Populations b. Value c. Bias

VI. Staff qualification

Big Data

I. Data management activities a. Plan b. Data query c. Electronic data

II. Case Report Form a. Essential documentation, subject related and non-subject related (e.g., past medical

records, lab reports, protocol, IRB approvals) III. Meta-Data

a. Storage b. Purpose c. How used


Understand the Evidence Based Medicine, Personalized Medicine, Big Data Requirements:



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Recommended Textbooks: Friedman, L., Furberg, C., DeMets, D. (2010). Fundamentals of clinical trials (4th ed.). New York, NY: Springer. Tal, J. (2011). Strategy and statistics in Clinical Trials: A non-

statisticians guide to thinking, designing and executing. Waltham, MA: Elsevier Inc.

Brody, T. (2012). Clinical Trials: Study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines. Waltham, MA: Elsevier Inc. Machin, D., Day, S., Green, S. (Eds.). (2006). Textbook of Clinical Trials (2nd ed.). West Sussex, England: John Wiley & Sons, Ltd.

Clinical Data Management - A Beginner's Guide by Kamal Akhtar 21 Code of Federal Regulations International Conference on Harmonization of Technical Requirements

for Registration of Pharmaceuticals for Human Use. (1996). ICH harmonized tripartite guideline: Guideline for good clinical practice (E6 [R1] current step 4 version). McGuire Dunn, C., Chadwick, G. (2004). Protecting study volunteers in research: A manual for investigative Sites (3rd ed.). Boston, MA: CenterWatch. Anderson, D. (2004). A guide to patient recruitment and retention. Boston, MA: CenterWatch. Woodin, K. (2011). The CRC’s guide to coordinating Clinical Research (2nd ed.). Boston, MA: CenterWatch. Woodin, K., Schneider, J. (2011). The CRA’s guide to monitoring Clinical Research (3rd ed.). Boston, MA: CenterWatch.