Postauthorization safety study of betaine anhydrous

HIGHLIGHTS

• who: Revised and collaborators from the investigator of the, HOD study center coordinating the registry (Heidelberg University Hospital [UKHD]) and under oversight of the, HOD consortium and the PRAC of the EMAPutative (severe) adverse events [(S)AEs] were primarily reported directly to the pharmacovigilance of the sponsor to honor legal timelines, but were additionally also entered into the registry. The coordinating investigator at UKHD was responsible for administrative management and communication with the local investigators, providing assistance to participating clinical sites in study management and record keeping, and acted as primary liaison with the sponsor providing the . . .
  

   

  

  If you want to have access to all the content you need to log in!

  Thanks :)

  Username or Email

  Password

  Remember me

  Lost your password?

  If you don't have an account, you can create one here.