How long should data be kept?
GDPR does not specify retention periods for personal data. Instead, it states that personal data may only be kept in a form that permits identification of the individual for no longer than is necessary for the purposes for which it was processed.
How long do you have to keep clinical research records?
2 years
When should research data be destroyed?
Most researchers will store data for at least five years after final publication. You need to keep data for a further five years if you re-analyse data and publish again. The table below outlines the standard time-frames for storing research data.
What is a serious breach of GCP?
Serious breaches of GCP or the Protocol The MHRA have a definition of a serious breach of GCP: a ‘serious breach’ is a breach that is likely to affect to a significant degree: the safety or physical or mental integrity of the participants; or. the scientific value of the trial.
What is the purpose of GCP?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.
What are the different phases of clinical trials?
Summary
| Phase | Primary goal |
|---|---|
| Phase 0 | Pharmacokinetics; particularly oral bioavailability and half-life of the drug |
| Phase I | Dose-ranging on healthy volunteers for safety |
| Phase II | Testing of drug on participants to assess efficacy and side effects |
| Phase III | Testing of drug on participants to assess efficacy, effectiveness and safety |
What is the purpose of a research protocol?
A research protocol is the guidebook for a research study. It describes what the researchers are intending to do and how they will do it. Writing a protocol ensures that all the major issues are considered in designing and developing a particular research project.
What are some examples of evidence-based practices?
There are many examples of EBP in the daily practice of nursing.
- Infection Control. The last thing a patient wants when going to a hospital for treatment is a hospital-acquired infection.
- Oxygen Use in Patients with COPD.
- Measuring Blood Pressure Noninvasively in Children.
- Intravenous Catheter Size and Blood Administration.