Standard Operating Procedure (SOP) Quiz

Who is responsible for preparing and maintaining the SOP procedure?

• CEO

• Project Manager

• Lead Statistician

• Chief Investigator

What must be described in a study protocol according to Good Clinical Practice (GCP) principles?

• Only the objective of the study

• Only the statistical considerations

• Only the design of the study

• The objective, design, methodology, statistical considerations, and organization of the study

Who should create a study protocol for Clinical Trials of Investigations Medicinal Products (CTIMPs)?

• Site Manager

• Chief Investigator

• Project Manager

• Lead Statistician

What must be done before an updated version of a paper Case Report Form (CRF) is released for use?

• Update the Data Monitoring Committee Charter

• Update the Adverse Event (AE) Log

• Update the version tracker

• Update the Subject Pre-Screening Log

Who is responsible for ensuring that members of the investigator site research team are qualified and informed of the study protocol?

• Lead Statistician

• Project Manager

• Principal Investigator

• Site Coordinator

What must be included in the footer of the Informed Consent Form (ICF) for version control?

• Only the study version number

• Only the page number

• Study version number, date, country version, and site specific version

• Only the date

Who must approve the final Country Specific ICF for an international study?

• Sponsor/DR designee

• Site Manager

• Lead Statistician

• GPM

What must be described in the Participant Information Sheet (PIS) to fulfill transparency requirements under the General Data Protection Regulation (GDPR)?

• Details of how participants' personal data will be used and their rights under the law

• Only the study objectives

• Only the study methodology

• Only the participant's rights under the law

Who will ensure that any new/amended study documents are not followed/used before approval has been received from the sponsor(s)?

• Subject Pre-Screening Team

• Data Monitoring Committee

• Site Staff

• Trial Team

What must be recorded in the Adverse Event (AE) Log?

• All Adverse Events (AEs)

• Only the mild Adverse Events

• All study participants' names

• Only the serious Adverse Events (SAEs)