| 1 x | Clinical Evaluation Report: Review for Regulatory Professionals | € 308.00 |
| 1 x | GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations | € 84.00 |
| 1 x | ISO 14155_课程1_范围 | € 143.00 |
| 1 x | test training for stg env | € 12.00 |
| 1 x | second video test | € 9.00 |
| 1 x | 临床试验的启动 | € 95.00 |
| 1 x | 临床试验关闭或终止 | € 66.00 |
| 1 x | US Safety Reporting Requirements during Pre-Market Clinical Trials | € 72.00 |
| 1 x | Duplicate of wmdos-34 | € 20.00 |
| 1 x | GCP for Investigators: Clinical Investigation Close out or Termination | € 66.00 |
| 1 x | Clinical Evaluation for Market Approval | € 616.00 |
| 1 x | GCP for Investigators: How to Qualify for Medical Device Clinical Investigations | € 95.00 |
| 1 x | GCP for Investigators: Introduction to Medical Devices | € 126.00 |
| 1 x | Managing Data Release Consent During Post Market Studies | € 75.00 |
| 1 x | European Safety Reporting Requirements during Clinical Investigations | € 90.00 |
| 1 x | Medical Device GCP for Investigators | € 120.00 |
| 1 x | Understanding Clinical Evaluation for Notified Body and Regulatory Professionals | € 544.00 |
| 1 x | GCP for Investigators: Initiation of a Medical Device Clinical Investigation | € 95.00 |
| 1 x | ISO 14155_课程3_临床试验策划 | € 180.00 |
| 1 x | ISO 14155_课程4_临床试验的开展 | € 143.00 |
| 1 x | Medical Device GCP – Investigator Certificate | € 255.00 |
| 1 x | ISO 14155_课程5_临床试验关闭 | € 90.00 |
| 1 x | Importance of Clinical Investigator´s Brochure (IB) | € 332.00 |
| 1 x | with video | € 22.00 |
| 1 x | Applying GDPR to Medical Devices Clinical Investigations | € 124.00 |
| 1 x | The European Medical Device New Regulation 2017/745 | € 925.00 |
| 1 x | with video /2222 | € 15.00 |
| 1 x | ISO 14155 GCP – Main Differences with ICH 6 clinical professionals should know | € 161.00 |
| 1 x | ISO 14155_课程7_主要研究者职责 | € 125.00 |
| 1 x | GCP for Investigators: Clinical Investigation Conduct and Reporting | € 128.00 |
| 1 x | 课程1：医疗器械简介 | € 120.00 |
| 1 x | wmdos-34 | € 20.00 |
| 1 x | Clinical Evaluation for Market Approval | € 352.00 |
| 1 x | 如何进行医疗器械临床试验相关资质评估 | € 95.00 |
| 1 x | Source Document Verification | € 108.00 |
| 1 x | The Close Down Visit | € 108.00 |
| 1 x | ISO 14155:2020 - Ethical Considerations | € 108.00 |
| 1 x | The Case Report Form Process | € 161.00 |
| 1 x | The Clinical Investigation Plan | € 161.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Close Out | € 90.00 |
| 1 x | ISO 14155:2020 - Certificate | € 580.00 |
| 1 x | Introduction to Good Clinical Practice | € 109.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Planning | € 180.00 |
| 1 x | Device Accountability | € 72.00 |
| 1 x | The Informed Consent Process | € 161.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Conduct | € 143.00 |
| 1 x | Adverse Event Processes | € 275.00 |
The Informed Consent Process
The Informed Consent Process
This course provides an in-depth review of the informed consent process requirements for the Declaration of Helsinki, the ISO 14155 standard, and 21 CFR 50. It offers detailed instructions on the writing and approval processes that must be implemented before clinical investigations begin, including details about special circumstances that may arise during the informed consent process.
This course also reviews the monitor’s role and the responsibilities of performing an informed consent process on site.
2 modules
€ 161.00
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