20181018

Update of Annexes II, V and VIIIC of the AEMPS for the conduct of clinical trials in Spain

The AEMPS has updated Annexes II, V and VIIIC for the conduct of clinical trials in Spain.

  • Annex II. Security documentation that the sponsor must send to the Health Authorities of the Autonomous Communities
  • Annex V. Model of insurance certificate
  • Annex VIIIC. Instructions for updating the section of Protection of personal data in the patient information sheet regarding the General Data Protection Regulation (EU) No. 2016/679

Clicking here you can access the annexes.

20181015

Use of electronic health record data in clinical investigations

Electronic health record (EHR) systems are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care.

The EHR systems can be an interesting chance in clinical investigation: to improve data accuracy and promote clinical trial efficiency, due to EHR systems can be used to integrate real-time electronic health care information, from medical devices and multiple health care providers involved in the care of patients. A typical individual EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results that can be combined, aggregated to others platforms, and analyzed. In addition, there are opportunities for long-term follow up of large numbers of patients, which may be of particular importance in studies where the outcome of interest occurs rarely, such as in prophylaxis studies.

For more information: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf