Instituto de Salud Carlos III (ISCIII)

This sponsor has funded 12 studies across 10 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3393 Ongoing Unspecified Evaluation of a Standardized Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy... Yes No
7718 Planned Unspecified Drugs as risk factors of unexplained sudden cardiac death (SCD). A case-control study Yes No
13969 Ongoing Not included in RMP Risk of lactic acidosis associated with metformin use in patients with type 2 diabetes and moderate-severe chronic kidney disease: a case-control... No No
19188 Ongoing Not included in RMP Use of antidepressant drugs and its association with risk of stroke, frequency of hospitalization, and mortality in an elderly population: a... Yes No
34349 Ongoing Not included in RMP Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients (COVIDSOT) (COVID-19) No No
34437 Ongoing Not included in RMP USE OF DRUGS ACTING ON RENIN-ANGIOTENSIN SYSTEM (RAS) AND RISK OF COVID-19: A CASE-POPULATION STUDY (SRAA-COVID19) Yes No
34443 Planned Not included in RMP SARS-CoV-2 viral load in the respiratory tract and in blood as factor associated to the clinical outcomes in adults with COVID-19 (COVID_CV) No No
34607 Finalised Not included in RMP Determination of phenotypes predicting complications in COVID-19 and evaluation of the efficacy of immunosuppressive treatments (INMUNOSUPR COVID-19) Yes Yes
34653 Planned Not included in RMP Pharmacogenetic study to predict the response to Tocilizumab in patients infected with SARS-CoV-2 (COVID-19) No No
34756 Ongoing Not included in RMP COVID-19 IN PATIENTS WITH HEART FAILURE AND INHERITED CARDIAC CONDITIONS (C19-ICC) No No
43186 Planned Not included in RMP FOUR-YEAR EFFECTIVENESS OF COVID-19 VACCINES AGAINST SEVERE DISEASE AND ASYMPTOMATIC INFECTION: THE COVIDVAC@SPAIN STUDY No No
44587 Ongoing Not included in RMP Effect of drug consumption before and during the SARS-COV-2 infection on the evolution of patients with COVID-19. A population-based study (COVIDrug) Yes No

PAS by Risk Management Plan (RMP) requirement

Instituto de Salud Carlos III (ISCIII)

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.