Management

ADM 001  Writing and Reviewing of SOP’s

ADM 002  Change Control for Revising or updating SOP’s

ADM 003  SOP: Investigator and Clinical Staff training

ADM 004  SOP: Computer System management

ADM 005  SOP: Document Control

ADM 006  SOP: Equipment calibration

 

Clinical Conduct

CCT   001  SOP on Obtaining Informed Consent from Clinical Trial Participant and where applicable Caregiver

CCT   002  SOP on doing an ECG in resting supine position

CCT   003  SOP: Procedure to record Vital Signs

CCT   004  SOP: Recording of height and weight

CCT   005  SOP: Interview to obtain demographic information, family-, medical-, and social history

CCT   006  SOP: Physical and Neurological examination

CCT   007  SOP: Blood samplings through vena puncture

CCT   009  SOP: Urine sampling

CCT   010  SOP: Management of oral investigational product

CCT   011  SOP: Development of Source data documents and keeping source data

CCT   012 SOP: Patient transport fees

CCT   013 SOP: Reporting Serious Adverse Events

 

Quality Assurance

AQ   001  SOP:  Quality Assurance