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Protocol Deviations: Documenting, Managing, and Reporting - April 18, 2019

Course #: BI13450
April 18, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance - April 22, 2019

Course #: BI13452
April 22, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series - June 04, 2019 - August 20, 2019

EARLY REGISTRATION
Course #: BI13374
June 4 - August 20, 2019 | Interactive Web Seminar
10:30 AM - 12:30 PM Eastern

Tuesday Mornings. No class July 2, July 9.


Take advantage of our $1615.50 price by registering early!
* After Friday, May 3, 2019, costs are $1795.50.
$1,615.50

Informed Consent Procedure: Lessons Learned from Inspection Findings - April 23, 2019

Course #: BI13440
April 23, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Case Report Form Design, Strategy, and Standards - April 24, 2019

Course #: BI13454
April 24, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Risk-Based Auditing: Effective Compliance Strategies - April 29, 2019

Course #: BI13457
April 29, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Monitoring Medical Device Trials: An Introduction - April 29, 2019

Course #: BI13458
April 29, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

NEW! Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs - April 30, 2019

Course #: BI13555
April 30, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components - April 30, 2019

Course #: BI13459
April 30, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

Course #: BI13460
April 30, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Monitoring Visit Reports for Medical Device Studies - April 30, 2019

Course #: BI13461
April 30, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Regulatory Intelligence - May 01, 2019

Course #: BI13462
May 1, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance - May 01, 2019

Course #: BI13463
May 1, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

CAP and CLIA Requirements for Clinical Research Laboratories - May 01, 2019

Course #: BI13464
May 1, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

30-Hour Clinical Research Auditing Certification Program - May 02, 2019 - July 18, 2019

Course #: BI13385
May 2 - July 18, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Thursday Mornings. No class July 4, July 11.

$1,795.50

Investigational Product Accountability Best Practices - May 02, 2019

Course #: BI13465
May 2, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs - May 02, 2019

Course #: BI13466
May 2, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$562.50

Current FDA and EMA Inspection Findings: Lessons Learned - May 02, 2019

Course #: BI13467
May 2, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies

Course #: BI13468
May 2, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$751.50

Root Cause Analysis: Applying the Concept for Better Study Compliance Management - May 03, 2019

Course #: BI13469
May 3, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$562.50

10-Week CRA & CRC Beginner Program - May 06, 2019 - July 29, 2019

Course #: BI13562
May 6 - July 29, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class May 27, July 1, July 8.

$1,795.50

NEW! Clinical Research Financial Management for Investigative Sites - May 06, 2019

Course #: BI13557
May 6, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Centralized TMF Management: The CRO Sponsor Partnership - May 07, 2019

Course #: BI13470
May 7, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

eTMF Implementation Strategies - May 07, 2019

Course #: BI13471
May 7, 2019 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
$751.50

Data Management Plan Creation: Content and Rationale - May 08, 2019

Course #: BI13472
May 8, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

The Fundamentals of Clinical Research Project Management - May 09, 2019

Course #: BI13473
May 9, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Trial Master Files: Why They Are Important and How to Organize Them Workshop - May 10, 2019

Course #: BI13474
May 10, 2019 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
$945.00

ABCs of GCP and the 13 Principles of ICH GCP E6 - May 10, 2019

Course #: BI13475
May 10, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

ABCs of Clinical Research for Clinical Administrative Support Staff - May 10, 2019

Course #: BI13476
May 10, 2019 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

Sponsor Management of Investigator Non-Compliance - May 13, 2019

Course #: BI13477
May 13, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Source Documentation: What is Adequate and Accurate? - May 13, 2019

Course #: BI13478
May 13, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Monitoring Plan Development - May 16, 2019

Course #: BI13479
May 16, 2019 | Interactive Web Seminar
8:30 AM - 10:30 AM Eastern
$661.50

CRA Current Practice Update: Impact of the FDA Bioresearch Monitoring (BIMO) Program - May 16, 2019

Course #: BI13480
May 16, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

10-Week Fundamentals of Clinical Research Series: Getting Started in Clinical Research - May 16, 2019 - August 01, 2019

Course #: BI13377
May 16 - August 1, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Thursday Afternoons. No class July 4, July 11.

$1,795.50

10-Week Clinical Research Associate (CRA) On-Boarding Program - May 17, 2019 - August 02, 2019

EARLY REGISTRATION
Course #: BI13370
May 17 - August 2, 2019 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern

Friday Mornings. No class July 5, July 12.


Take advantage of our $1615.50 price by registering early!
* After Friday, April 19, 2019, costs are $1795.50.
$1,615.50

10-Week Clinical Research Coordinator (CRC) On-Boarding Program - May 17, 2019 - August 02, 2019

EARLY REGISTRATION
Course #: BI13373
May 17 - August 2, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Friday Afternoons. No class July 5, July 12.


Take advantage of our $1615.50 price by registering early!
* After Friday, April 19, 2019, costs are $1795.50.
$1,615.50

Essential Documentation in Clinical Trials at Research Sites - May 20, 2019

Course #: BI13481
May 20, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

NEW! Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles - May 21, 2019

Course #: BI13560
May 21, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

FDA Drug Approval Process - June 03, 2019

Course #: BI13482
June 3, 2019 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern
$661.50

eSource and Mobile Technology Initiatives: Data Management Considerations - May 22, 2019

Course #: BI13483
May 22, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Leading Teams in a Changing Clinical Research Environment - May 22, 2019

Course #: BI13484
May 22, 2019 | Interactive Web Seminar
2:30 PM - 4:30 PM Eastern
$661.50

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning - May 23, 2019

Course #: BI13485
May 23, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

The GCPs of Essential Documents - May 23, 2019

Course #: BI13486
May 23, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Case Report Form Design, Strategy, and Standards Workshop - May 28, 2019

EARLY REGISTRATION
Course #: BI13487
May 28, 2019 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern

Take advantage of our $765.000 price by registering early!
* After Friday, April 26, 2019, costs are $945.000.
$765.00

FDA Medical Device Approval Process - May 28, 2019

Course #: BI13488
May 28, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Risk-Based Monitoring: The Data Management Connection - May 29, 2019

Course #: BI13489
May 29, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Writing and Updating the Investigator's Brochure

Course #: BI13490
May 29, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Developing and Negotiating Research Site Clinical Study Budgets and Contracts - May 30, 2019

Course #: BI13491
May 30, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance - May 31, 2019

Course #: BI13492
May 31, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

NEW! 10-Week Clinical Research Financial Certification Program: Setting Up Compliant Financial Operations and Budgets - June 03, 2019 - August 19, 2019

EARLY REGISTRATION
Course #: BI13388
June 3 - August 19, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class July 1, July 8)


Take advantage of our $1615.50 price by registering early!
* After Friday, May 10, 2019, costs are $1795.50.
$1,615.50

Overseeing Teams and Projects - June 03, 2019

Course #: BI13493
June 3, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Preparation, Management, and Response to Inspections and Audits - June 04, 2019

Course #: BI13494
June 4, 2019 | Interactive Web Seminar
10:00 AM - 2:00 PM Eastern
$940.50

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques - June 04, 2019

Course #: BI13495
June 4, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$850.50

Managing CRAs to Improve Performance and Study Outcomes - June 04, 2019

Course #: BI13496
June 4, 2019 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern
$562.50

Sponsor Responsibilities for Global Drug Studies - June 04, 2019

Course #: BI13497
June 4, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Strategies for Managing Difficult Clinical Research Sites - June 05, 2019

Course #: BI13499
June 5, 2019 | Interactive Web Seminar
8:30 AM - 10:30 AM Eastern
$751.50

Quality Systems: A Controlled Approach to GCP Compliance - June 05, 2019

Course #: BI13498
June 5, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

The IND in a CTD/eCTD Format - June 05, 2019

Course #: BI13500
June 5, 2019 | Interactive Web Seminar
2:30 PM - 4:00 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

30-Hour Clinical Data Management On-Boarding Program - June 05, 2019 - August 28, 2019

EARLY REGISTRATION
Course #: BI13381
June 5 - August 28, 2019 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern

Wednesday Evenings. No class July 3, July 10, August 7.


Take advantage of our $1615.50 price by registering early!
* After Friday, May 3, 2019, costs are $1795.50.
$1,615.50

10-Week CRA & CRC Beginner Program - June 05, 2019 - August 28, 2019

EARLY REGISTRATION
Course #: BI13369
June 5 - August 28, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings. No class July 3, July 10, August 7.


Take advantage of our $1615.50 price by registering early!
* After Friday, May 3, 2019, costs are $1795.50.
$1,615.50

Cases in Advanced GCP: A Problem-Solving Practicum - June 06, 2019

Course #: BI13501
June 6, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings - June 06, 2019

Course #: BI13502
June 6, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$562.50

Implications of the FDA Guidance for a Risk-Based Approach to Monitoring and EMA Reflection Paper Risk Based Quality Management in Clinical Trials - June 06, 2019

Course #: BI13503
June 6, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Monitoring Reports: 10 Rules of Effective Report Writing - June 07, 2019

Course #: BI13504
June 7, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

NEW! Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials - June 07, 2019

Course #: BI13552
June 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

TMF/eTMF Audit Strategies - June 07, 2019

Course #: BI13505
June 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

The Revised HHS Common Rule: What You Need to Know Now - June 10, 2019

Course #: BI13506
June 10, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

Introduction to Statistics for Non-Statisticians - June 11, 2019

Course #: BI13508
June 11, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Risk-Based Site Monitoring - June 11, 2019

Course #: BI13507
June 11, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Preparing Clinical Research Sites for FDA Inspections - June 12, 2019

Course #: BI13509
June 12, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$562.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs - June 12, 2019

Course #: BI13510
June 12, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites - June 13, 2019

Course #: BI13511
June 13, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

eTMF Quality Oversight: A Risk-Based Approach - June 14, 2019

Course #: BI13512
June 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings - June 14, 2019

Course #: BI13519
June 14, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

NEW! Establishing Quality Tolerance Limits - June 18, 2019

Course #: BI13546
June 18, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

NEW! Implementing Quality Agreements - June 18, 2019

Course #: BI13547
June 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Strategies for Active Listening - June 18, 2019

Course #: BI13514
June 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring - June 18, 2019

Course #: BI13515
June 18, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Subject Recruitment: Proactive Project Plans and Issues Management - June 19, 2019

Course #: BI13516
June 19, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$562.50

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials - June 20, 2019

Course #: BI13517
June 20, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets - June 20, 2019

Course #: BI13518
June 20, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Drug Development and FDA Regulations - July 16, 2019

Course #: BI13520
July 16, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$661.50

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance - July 16, 2019

Course #: BI13521
July 16, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

NEW! Coaching Skills for Leaders - July 16, 2019

Course #: BI13522
July 16, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Introduction to Data Management - July 17, 2019

Course #: BI13523
July 17, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

NEW! Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance for Industry - July 17, 2019

Course #: BI13553
July 17, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Writing Clinical Study Protocols - July 17, 2019

Course #: BI13524
July 17, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada - July 17, 2019

Course #: BI13525
July 17, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry - July 18, 2019

Course #: BI13527
July 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Strategies for Having Difficult Conversations - July 18, 2019

Course #: BI13526
July 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Use of Notes to File in Clinical Trial Essential Documentation - July 19, 2019

Course #: BI13528
July 19, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$751.50
$751.50

NEW! Incorporating Denials Management into Clinical Research Billing - July 23, 2019

Course #: BI13530
July 23, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Final ICH GCP E6 R2: Impact on Clinical Data Management - July 24, 2019

Course #: BI13531
July 24, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Writing the Clinical Study Report - July 24, 2019

Course #: BI13532
July 24, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance - July 25, 2019

Course #: BI13533
July 25, 2019 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components - July 29, 2019

Course #: BI13534
July 29, 2019 | Interactive Web Seminar
8:30 AM - 11:00 AM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

Advanced Clinical Research Coordinator Training: Moving Your Career to the Next Level - July 31, 2019

Course #: BI13536
July 31, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50