Clinical Activity/Coordination

Drug Accountability

Reconcilation of drugs used for protocol treatment, including communication with pharmacy or drug supply.

Patient Care

Clinical research management of patients. This includes time in clinic & with physicians, chart reviews, protocol reviews, travel time to/from pharmacy, CRC, preparation for an appointment, & general patient management that is not related to general screening activities. Includes tumor measurements.

Patient Consent or Re-Consent Review of consent with patient and documentation of

consent process. Patient Education

Discussion of study processes & procedures with patients. “Not” including consenting.

Scheduling Patient scheduling for all clinical procedures/visits,

including review of future visits & procedures Source documentation completion Examples: putting a note in EPIC, lab signoffs, CT scan

measurements

Data Management

Query Resolution, completion of corrective actions, & NTF

Review and completion of data queries & followup on corrective actions. Notes to file. Research Chart Mgmt

Assembly & organization of research and clinic chart. Includes boxing up charts for close out.

CRF Completion Completion of all electronic or paper CRFs. OnCore - Subject Entry of patient accrual, off treatment, off study, etc.

SAESAE

All data collection, source document completion specific for the SAE event, and SAE form completion, including PI review & signature.

Screening and Enrollment Logs

Review and completion of enrollment and screening logs.Source document development Develop documents to manage patient, including changes due to amendments. Subject Registration Registering subject through IVRS or sponsor. Also includes documentation to DSMC.

Protocol Training/Meetings

eCRF Training

On-line training

GCP Training

On-line training

Internal Training & Meetings

Reviewing internal procedures & processes for protocol startup. Include ongoing meetings to discuss trial activity

Investigator or Cooperative Group meetings

Time spent on investigator or cooperative group meetings including travel.

Protocol Training/Meetings

Protocol Review

Review of protocol for research related procedures & logistics, including budgeting.

Site initiation/Start up visit/Retraining

Preparation and time spent on start-up meeting.

Site selection visit

Completion of paperwork for site selection. Scheduling of site visit and time spent with sponsor/CRO during a site selection visit.

Training – Other

On-line training beyond eCRF or GCP training