General Study Procedures Clause Samples

General Study Procedures. All assessments for each participant will be performed by the study investigator(s) and / or appropriately delegated center staff according to the Schedule of Assessments Every effort must be made to adhere to the Schedule of Assessments. Participants who are unable to make a required study visit should be encouraged to return to the clinic within the specified visit window to complete study assessments. In general, scheduled visits will include assessment of adverse events, concomitant medications, treatments and blood samples for various laboratory tests. All adverse events, concomitant medications, treatments and visit assessments will be documented on eCRFs. All participants must sign the current IRB / IEC approved, protocol-specific informed consent form prior to undergoing any protocol specific evaluations and or procedures.