This document outlines various clinical research activities and provides descriptions for each. It includes activities such as drug accountability, patient care, obtaining informed consent, patient education, scheduling, data management including query resolution, research chart management, case report form completion, safety reporting, screening and enrollment log management, source document development, subject registration, protocol training, meetings, and general protocol review.

1. 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.

2. 
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

3. 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.

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

5. 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.

6. 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.

7. 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