| 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 |
| 1 x | Initiation Visit | € 161.00 |
| 1 x | ISO 14155:2020 - Scope | € 143.00 |
| 1 x | Introduction to Medical Device and Clinical Investigation Planning | € 161.00 |
| 1 x | Deviations and Non-Compliance Handling | € 54.00 |
| 1 x | Effective Monitoring of Medical Device Clinical Investigations | € 1’517.00 |
ISO 14155:2020 - Clinical Investigation Planning
ISO 14155:2020 - Clinical Investigation Planning
This course describes all activities involved in the clinical investigation planning process.
It covers the following topics:
- Risk assessment
- Justification of the investigational design,
- Clinical Investigation Plan (CIP),
- Investigator Brochure (IB),
- Case Report Form (CRF) requirements
- Monitoring plan,
- Site selection,
- Investigation agreements,
- Labeling requirements,
- Set up of data monitoring committee.
2 modules
€ 180.00
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