Assuring Data Integrity in Clinical Research
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Price: $195.00 USD  |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Assuring Data Integrity in Clinical ResearchTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Protect your clinical trial credibility by ensuring data is complete, consistent, and accurate. This course details how trial sponsors, investigators, and research staff can meet data integrity requirements and avoid costly regulatory actions.
Includes training on FDA's 21 CFR Part 11 and European Union's (EU) Good Manufacturing Practice (GMP) Annex 11: Computerized Systems. Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
Outline:Data integrity definitions and fundamentals What do we mean by data; What is data integrity; ALCOA, ALCOA+ and ALCOA++; Source data and metadata; Transcription and transformation of data; Static and dynamic data; Certified copies; Archiving and retention; Validation of computerized systems; Data governance; Safeguarding of blinding; Regulators; and responses to data integrity failings. Integrity of paper-based data Document control; Recording data by hand; Correcting handwritten data; Submitting paper CRFs to sponsor; Storage, archiving and retention of paper records. Integrity of electronic data Electronic source data and originators; Entry of data to an eCRF; Calibration of instruments; Remote data acquisition; Restrictions on access to computerized systems; Manual data entry; Verification of data; Audit trails and other metadata; Modifications and corrections; Review and sign-off of data; Protection of data; Storage, backup and archiving; Data transfer and migration; Electronic signatures. | Objectives:Who will benefit from this module? This module provides essential learning for all healthcare professionals participating in clinical research, and all clinical development staff of medicinal products and medical device manufacturers Learning objectives - Describe basic principles of data integrity assurance - Comply with regulatory requirements and good practices for the assurance of paper-based data in clinical research - Comply with regulatory requirements and good practices for the assurance of electronic data in clinical research Level: Introductory Audience: Healthcare professionals participating in clinical research; clinical development staff of medicinal products and medical device manufacturers Categories: Information and communication technology; Clinical trials; Medical devices; Good practices for regulated laboratories Region: Europe, USA, other Includes training on FDA's 21 CFR Part 11 and European Union's (EU) Good Manufacturing Practice (GMP) Annex 11: Computerized Systems. | |
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Benefits of Training with Biopharma Institute
| Immediate Course Access: | Login details, instructions, and payment confirmation are emailed immediately upon online enrollment. |
| Self-Paced eLearning: | Enjoy 24/7 access to all course materials and assessments for 12 months. |
| Open Enrollment: | No prerequisites or prior work experience required to start. |
| Expert-Developed Content: | Courses are designed by subject matter experts (SMEs) in their respective fields. |
| Up-to-Date & Validated: | Training is regularly updated to meet current regulations and is third-party validated or accredited. |
| Optimized for Learning: | Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention. |
| Secure Access: | Encrypted connections, firewalls, and daily malware scans ensure security and system performance. |
| Flexible Assessments: | Multiple-choice exams can be retaken until a passing score is achieved. |
| Instant Certificates: | Certificates are issued instantly in secure PDF format with watermark, unique validation code, and QR code for verification. |
| Training Verification: | Certificates can be verified online using a QR code or unique ID. Digital badges are included with professional certifications. |
| Manager Access: | A secure portal allows managers to view and download enrollment reports, training records, account balances, and more. |
| SCORM-Compliant: | Courses can be integrated directly into most corporate Learning Management Systems (LMS). |
| Purchase Orders: | We accept POs from all companies. Request an invoice to start the procurement process. |
| Employer Reimbursement: | Some employers may cover training costs -check your company's reimbursement policy. |
| Financial Assistance: | Payment plans are available for eligible learners, or purchase courses individually as needed. |
| Career Advancement: | Professional certifications highlight dedication to career growth, enhance resumes, provide interview talking points, and equip learners with practical job skills. |
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