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Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters (e.g., PQ, OQ, PQ/OQ, /, \, (, ), etc.) will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, CFR Part 820, Cleaning Validation, or Drug Safety.

  


Searching courses for: Clinical Trials


(41 Programs Found)

Certification Training Clinical Trials:  How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

Clinical Trials: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation

To conduct a clinical trial in one or more member states (MSs) of the European Economic Area (EEA) a sponsor must first gain the approval of each relevant national regulator and the favourable opinion …
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Course ID: CT11
PRICE: $225 | Enroll Now >>
Certification Training Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation

The European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the European Economic Ar …
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Course ID: CT12
PRICE: $175 | Enroll Now >>
Certification Training Clinical Trials: Preparation and Design
Individual Course w/Certificate of Completion:

Clinical Trials: Preparation and Design

Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical tria …
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Course ID: GCP002
PRICE: $225 | Enroll Now >>
Certification Training Clinical Trials:  How to Obtain Approval to Conduct Clinical Trials in the EU
Individual Course w/Certificate of Completion:

Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

To conduct a clinical trial in the European Economic Area the sponsor must apply for authorization from the national competent authority (i.e. medicines regulator), and favorable opinion must be obtai …
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Course ID: GCP020
PRICE: $175 | Enroll Now >>
Certification Training Clinical Trials and Drug Development
Individual Course w/Certificate of Completion:

Clinical Trials and Drug Development

This course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials are outlined. …
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Course ID: GCP003
PRICE: $175 | Enroll Now >>
Certification Training Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)
Individual Course w/Certificate of Completion:

Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)

From the EU Clinical Trials Directive to the Clinical Trials Regulation, the content includes an overview of the requirements for the conduct of clinical trials in the European Union, the EU Regulatio …
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Course ID: CP018a
PRICE: $199 | Enroll Now >>
Certification Training EU-MDR - Chapter VI - Clinical Evaluation and Clinical Investigations
Individual Course w/Certificate of Completion:

EU-MDR – Chapter VI – Clinical Evaluation and Clinical Investigations

This is a significant and exciting chapter introducing a life-cycle approach to ongoing CE Marking compliance; it is a process, not a project. One output of the clinical evaluation process is demonstr …
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Course ID: ELM-322
PRICE: $199 | Enroll Now >>
Certification Training Clinical Trials Monitoring Professional Certification Program for CRAs
Professional Certification Program:

Clinical Trials Monitoring Professional Certification Program for CRAs

GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensur …
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Course ID: GCP00A
PRICE: $845 | Enroll Now >>
Certification Training Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals
Training Program For Professionals:

Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals

This professional certification program is designed for regulatory affairs managers and directors, project managers, or clinical research associates and coordinators with desire to grow their career i …
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Course ID: GCP00A2
PRICE: $895 | Enroll Now >>
Certification Training GCP: ICH-GCP Good Clinical Practice
Individual Course w/Certificate of Completion:

GCP: ICH-GCP Good Clinical Practice

Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP …
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Course ID: GCP001
PRICE: $195 | Enroll Now >>
Certification Training Clinical Trials Management (US & EU) Professional Certification Program
Professional Certification Program:

Clinical Trials Management (US & EU) Professional Certification Program

This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also available to those …
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Course ID: GCP00A1
PRICE: $1295 | Enroll Now >>
Certification Training Clinical Trials:  Preparing for an Audit or Inspection
Individual Course w/Certificate of Completion:

Clinical Trials: Preparing for an Audit or Inspection

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the res …
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Course ID: GCP006
PRICE: $225 | Enroll Now >>
Certification Training Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA
Individual Course w/Certificate of Completion:

Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA

The Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational …
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Course ID: GCP007
PRICE: $225 | Enroll Now >>
Certification Training The General Data Protection Regulation (GDPR) and Clinical Trials
Individual Course w/Certificate of Completion:

The General Data Protection Regulation (GDPR) and Clinical Trials

This course covers the exchange of personal data from the European Union (EU) to the United States (US) while following the requirements of the EU’s General Data Protection Regulation. Content include …
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Course ID: CP009a
PRICE: $199 | Enroll Now >>
Certification Training Clinical Trial Monitoring: Documentation and Closure
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Documentation and Closure

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and …
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Course ID: GCP005
PRICE: $195 | Enroll Now >>
Certification Training Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline
Individual Course w/Certificate of Completion:

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

ICH E8(R1) is the umbrella guideline that maps to all the ICH E family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and …
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Course ID: CP019a
PRICE: $199 | Enroll Now >>
Certification Training Good Clinical Practice for Professionals
Training Program For Professionals:

Good Clinical Practice for Professionals

Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonization (ICH) for the design, conduct, performance, monitoring, aud …
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Course ID: GCPFP
PRICE: $495 | Enroll Now >>
Certification Training GCP: An Introduction to Good Clinical Practices - Part 3 of 3
Individual Course w/Certificate of Completion:

GCP: An Introduction to Good Clinical Practices – Part 3 of 3

This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol p …
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Course ID: ELM-903
PRICE: $199 | Enroll Now >>
Certification Training Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Individual Course w/Certificate of Completion:

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of …
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Course ID: PRA05
PRICE: $225 | Enroll Now >>
Certification Training Clinical Trial Monitoring: Site Evaluation and Set-up
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Site Evaluation and Set-up

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to b …
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Course ID: GCP004
PRICE: $175 | Enroll Now >>
Certification Training HIPAA Training for Clinical Trial Professionals
Individual Course w/Certificate of Completion:

HIPAA Training for Clinical Trial Professionals

HIPAA’s requirements for the use and disclosure of PHI during the conduct of a clinical trial is not simple and depends on the situation. But there is a way to use a core set of principles and questio …
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Course ID: CP017a
PRICE: $199 | Enroll Now >>
Certification Training Investigator Initiated Clinical Trials
Individual Course w/Certificate of Completion:

Investigator Initiated Clinical Trials

A sponsor-investigator refers to an individual who both initiates and conducts the clinical trial. Obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. A …
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Course ID: CP011a
PRICE: $199 | Enroll Now >>
Certification Training DIGR-ACT® Solution: Critical Thinking Skills
Individual Course w/Certificate of Completion:

DIGR-ACT® Solution: Critical Thinking Skills

DIGR-ACT® is a process developed by industry experts to improve critical thinking skills in relation to clinical trials. It helps clinical trial team members manage issues and risks that matter, t …
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Course ID: CP001a
PRICE: $399 | Enroll Now >>
Certification Training EU Medical Device Regulation (EU MDR) for Professionals
Training Program For Professionals:

EU Medical Device Regulation (EU MDR) for Professionals

This program includes 9 separate courses or training modules. The learning objectives of these modules are described here. An introductory course is used to explain how, why, and when the new regulati …
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Course ID: EUMDR
PRICE: $1295 | Enroll Now >>
Certification Training ICH E6(R2) GCP Training for Investigator Site Personnel
Individual Course w/Certificate of Completion:

ICH E6(R2) GCP Training for Investigator Site Personnel

This Investigator Site Personnel Good Clinical Practice (GCP) course covers the requirements of GCP for clinical trials found in ICH E6(R2) related to the role of the investigator and site personnel, …
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Course ID: CP004a
PRICE: $199 | Enroll Now >>
Certification Training Structure and Content of Clinical Study Reports (ICH E3)
Individual Course w/Certificate of Completion:

Structure and Content of Clinical Study Reports (ICH E3)

This course covers the ICH E3 Guidance as well as the E3 Questions and Answers complement. Content includes an overview of ICH E3, an overview of the clinical study report or CSR, the body of the clin …
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Course ID: CP013a
PRICE: $199 | Enroll Now >>
Certification Training GCP: An Introduction to Good Clinical Practices - Part 1 of 3
Individual Course w/Certificate of Completion:

GCP: An Introduction to Good Clinical Practices – Part 1 of 3

Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonization (ICH) for the design, conduct, performance, monitoring, aud …
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Course ID: ELM-901
PRICE: $199 | Enroll Now >>
Certification Training Drug Safety: Signal Detection and Management in Pharmacovigilance
Individual Course w/Certificate of Completion:

Drug Safety: Signal Detection and Management in Pharmacovigilance

The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then ta …
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Course ID: PV04
PRICE: $195 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 2 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 2 of 3

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturin …
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Course ID: ELM-146
PRICE: $199 | Enroll Now >>
Certification Training Medical Device vs. Drug: Comparing and Contrasting
Individual Course w/Certificate of Completion:

Medical Device vs. Drug: Comparing and Contrasting

This course covers major differences between medical device and drug clinical trials, including key definitions, regulatory approval and application processes, and safety reporting, with a focus on F …
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Course ID: CP010a
PRICE: $199 | Enroll Now >>
Certification Training GCP Training Refresher
Individual Course w/Certificate of Completion:

GCP Training Refresher

This Good Clinical Practice (GCP) Refresher course reviews the major requirements of GCP for clinical trials according to the global guideline ICH E6(R2) related to roles and responsibilities using in …
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Course ID: CP003a
PRICE: $199 | Enroll Now >>
Certification Training Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)
Individual Course w/Certificate of Completion:

Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)

This course covers an overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA). Content includes 21 CFR Part 312 relatin …
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Course ID: CP015a
PRICE: $199 | Enroll Now >>
Certification Training Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects (HSP) [Part 1 of 2]
Individual Course w/Certificate of Completion:

Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 1 of 2]

According to the Code of Federal Regulations, 21 CFR Part 50 applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, …
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Course ID: ELM-909
PRICE: $199 | Enroll Now >>
Certification Training Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects (HSP) [Part 2 of 2]
Individual Course w/Certificate of Completion:

Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 2 of 2]

According to the Code of Federal Regulations, 21 CFR Part 50 applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, …
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Course ID: ELM-910
PRICE: $199 | Enroll Now >>
Certification Training GCP Training: ICH E6(R2)
Individual Course w/Certificate of Completion:

GCP Training: ICH E6(R2)

This GCP Training: ICH E6(R2) course overviews key components of the requirements of GCP for clinical trials found in ICH E6(R2) related to the role and responsibilities of the investigator, sponsor, …
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Course ID: CP002a
PRICE: $199 | Enroll Now >>
Certification Training Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC
Individual Course w/Certificate of Completion:

Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC

This course covers an Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC. Content includes key components of human subject protection, definitions and scope for Part …
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Course ID: CP014a
PRICE: $199 | Enroll Now >>
Certification Training Good Documentation Practices and ALCOA-C
Individual Course w/Certificate of Completion:

Good Documentation Practices and ALCOA-C

In this course, you will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. Good Documentation Practices are necessa …
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Course ID: CP005a
PRICE: $199 | Enroll Now >>
Certification Training Regulatory Affairs: Essentials for Human Medicinal Products - EU and US
Individual Course w/Certificate of Completion:

Regulatory Affairs: Essentials for Human Medicinal Products – EU and US

This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in or …
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Course ID: PRA01
PRICE: $225 | Enroll Now >>
Certification Training cGMP: Combination Products for Professionals
Training Program For Professionals:

cGMP: Combination Products for Professionals

This 3-part program will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manu …
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Course ID: COMPR
PRICE: $495 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 1 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 1 of 3

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturin …
(Learn more)

Course ID: ELM-145
PRICE: $199 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 3 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 3 of 3

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturin …
(Learn more)

Course ID: ELM-147
PRICE: $199 | Enroll Now >>