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GCP 2: Good Clinical Practice, Level 2

GCP 2: Good Clinical Practice, Level 2 Certification Training


Program/Course ID:GCPR2
Enrollment Period:12 months.
Average Learning Time:~.
Additional Resources:Supplemental materials/activities.
Credit Hours:3 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 UPDATE:
This program is currently unavailable for enrollment.

It may have been updated or discontinued.
Check for newer version in our catalog.


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Outline:


INTRODUCTION
1. Course Information
2. Interface Tour
3. Course Overview

STUDY START-UP:RESPONSIBILITIES
4. Objectives
5. GCP Guidelines
6. Investigator`s Responsibilities
7. Sponsor`s Responsibilities
8. Recordkeeping for Investigators
9. Recordkeeping for Sponsors and Monitors
10. The Evaluation Visit
11. Progress Check

STUDY START-UP: PROTECTION OF SUBJECTS
12. Objectives
13. Purpose of IRBs
14. Investigator-IRB Relationship
15. IRB Records and Reviews
16. Informed Consent: General Requirements
17. Informed Consent Process
18. The Informed Consent Document
19. Progress Check

DURING THE STUDY
20. Objectives
21. Investigator`s Responsibilities
22. Recordkeeping for Investigators
23. Investigator-IRB Interactions
24. Handling Investigational Product
25. Managing Adverse Events
26. Regulatory Evaluations
27. Progress Check

AFTER THE STUDY
28. Objectives
29. Preparing for an Audit
30. Record-keeping
31. Disqualification
32. Progress Check

Objectives:


Explain the role GCP plays in ensuring subjects are protected.
List the investigator and sponsor`s responsibilities prior to study start-up.
Describe the documents found in a study file.
Explain the purpose of the evaluation visit.
List the functions of Independent Review Boards (IRBs or IECs).
Describe the investigator-IRB interaction.
Explain how informed consent is achieved.
List the essential elements of the informed consent document.
List the investigator`s ongoing responsibilities during a clinical trial.
List the documents maintained during a clinical trial.
Describe the interactions between an investigator and IRB once the clinical trial has commenced.
Explain how the investigator maintains accountability of the investigational product.
Describe how adverse events are recorded and reported. Explain what is meant by a `complete` record.
Describe the types of records that must be kept following NDA approval, or the termination of a clinical trial.
Describe the process of disqualification.

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:


Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.