Show:
Prep/Shut down
Clinical / Communication
Data Mgmt
Med Writing
BCGI
100
Initial meeting with client and Beardsworth to review project assumptions, which takes place after contract signature.
What is Kick off meeting
100
Regulary scheduled internal team meetings
What is Team meetings and Communications
100
Reviewing SAE's in the clinical database against the safety database
What is SAE Reconciliation
100
Writing and editing of CSRs, as well as other documents that may not have specific writing codes (such as briefing books); also covers e-mail communications related to preparing CSRs and other documents
What is Create Final Study Report
100
Feasibility, Bid defense, RFP response.
What is BD: Proposal Development
200
Initial project team training with CRAs, PM, vendors and study sites.
What is Attendance at CRA Training/Investigator Meeting
200
Review of essential regulatory documents during the study.
What is On-going regulatory review
200
Addressing and identifying problematic data during data review
What is Query generation/resolution
200
Word processing and dealing with e-mails
What is Administration - Medical Writing
200
Answering front desk phone and door.
What is Admin: office admin
300
Occurs annually and at study close and is done to ensure complete and accurate study documentation.
What is Internal File Audit
300
Regulary scheduled calls to the sites to discuss enrollment, compliance, pharmacy issues, etc.
What is site maintenance
300
Run programs (ad hoc, discrepancy listings, exception report) used to support the review of clinical data
What is Data Review
300
Finding source documents for and creating CSR appendices and cover pages; includes bookmarking and hyperlinking of final PDF versions of appendices
What is Appendix Assembly
300
Yellow cards, CRA 12 hour rule and early dismissal.
What is Time off: Excused absence
400
Inventory, boxing and shipping all study material.
What is Study Completion
400
Development and documentation for study related procedures for investigative sites. Includes all study managment plans, pharmacy manual and investigator binder.
What is Operations Manual
400
Testing the system for functionality, edit specifications and ensuring that the CRF design meets the protocol requirements
What is UAT Procedures
400
Prepare patient narratives for CSR for patients with SAEs or other AEs of special interest, not to be confused with SAE event narratives, which are covered under SAE reporting code under clinical codes
What is SAE Narrative
400
Development of SOPs, development and maintenance of the internal processes and improvements within Beardsworth.
What is General: Infastructure Project
500
Review of protocol and all associated project material. Including BNET protocol test.
What is Initial Project Prep and Launch
500
Performing project manager assigned tasks including updates to BNET, processing screening and enrollment logs, communication with CRAs, ordering drug and preparation of SIV boxes. Does not include regulatory document collection, meeting minutes/agendas, attendance at telecons, newsletters or regularily scheduled site maintenance.
What is Monthly Administrative Support
500
The project data managers communication with sites or team members regarding EDC or data issues
What is Monthly DM Project Management
500
Prepare patient narratives for CSR for patients who discontinued the study due to AEs
What is DC Narrative
500
Hours not billable to a client or Beardsworth specific activity.
What is un-utilized time