GVP Module XVI Addendum II – Methods for effectiveness evaluation (Draft for Public Consultation)
GVP Module XVI Addendum II – Methods for effectiveness evaluation (Draft for Public Consultation)
On 01 Feb 2021, EMA has released a draft Regulatory and procedural guideline on “GVP Module XVI Addendum II – Methods for effectiveness evaluation” for Public Consultation
The document contains the following Table of contents
GVP Module XVI Addendum II – Methods for effectiveness evaluation (Draft for Public Consultation)
| XVI.Add.II. | 1.Introduction |
| XVI.Add.II. | 2.Data collection |
| XVI.Add.II. | 2.1. Data sources |
| XVI.Add.II. | 2.1.1. Qualitative research |
| XVI.Add.II. | 2.1.2. Surveys |
| XVI.Add.II. | 2.1.3. Registries |
| XVI.Add.II. | 2.1.4. Medical records |
| XVI.Add.II. | 2.1.5. Administrative claims |
| XVI.Add.II.
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2.1.6. Healthcare record linkage |
| XVI.Add.II. | 2.1.7. Spontaneous reports of suspected adverse reactions |
| XVI.Add.II. | 2.2. Factors influencing the choice of data source(s) |
| XVI.Add.II. | 3.Research methods |
| XVI.Add.II. | 3.1. Qualitative methods |
| XVI.Add.II. | 3.2 Survey methods |
| XVI.Add.II. | 3.3. Methods evaluating behaviour and health outcomes |
| XVI.Add.II. | 3.3.1. Single time point cross-sectional study |
| XVI.Add.II. | 3.3.2. Before/after cross-sectional study |
| XVI.Add.II. | 3.3.3. Before/after time series analysis |
| XVI.Add.II. | 3.3.4. Cohort study |
| XVI.Add.II. | 3.3.5. Randomised trial |
| XVI.Add.II. | 4.Reporting results of effectiveness evaluation |
| XVI.Add.II. | 4.1. Study registration in the EU PAS Register |
| XVI.Add.II. | 4.2. Checklist for harmonised reporting of study results |
Comments should be provided using this template. The completed comments form should be sent to gvp@ema.europa.eu.
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GVP Module XVI – Risk minimisation measures (Draft for Public Consultation)
