Spreadsheet: 80012d1280254651-use-indirect-pull-data-from-multiple-wbs-into-consolidating-ws-pu-7312129
Sheet: Cover Sheet

 |  |  |  |  |  |  |  |  |  | 2010-12-31 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Oper Unit | Sites | Site abrev
 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50287 | [NAME] | AUS
 |  | Project Leader: |  |  | CVD | Information as of Current Period: |  | 2010-07-15 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50380 | Basel | [NAME]
 |  |  |  |  | Contractor | Enter Contractor Name Here |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50285 | Boise | BOI
 |  | CVD Study #: | 7312129 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50288 | Dallas | DAL
 |  | COMS #: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50282 | Daytona Beach | DAB
 |  | Protocol: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50280 | Evansville | EVV
 |  | Client Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50283 | Gainesville | GAI
 |  | Client Name |  | i |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50284 | Honolulu | HON
 |  | Contact |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50320 | Leeds | LDS
 |  | Telephone Number(s) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50180 | [NAME] | MSN
 |  | E-mail Address |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 51180 | Madison ECD | MAD
 |  | General Study Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50286 | Portland | POR
 |  | Study Phase |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 50281 | San Diego | SAD
 |  | Type of Study
 |  | Drug
 |  | Indication/Patient Population
 |  | CVD Units Involved |  | CRU |  |  | Bio-Analytical:
 |  |  |  | CRU- LEEDS |  |  | Metabolism (CLNA)
 |  |  |  | Pharmacometrics |  |  | DSS (LSDS)
 |  |  |  | Regulatory (LSDS) |  |  | GEMS
 |  |  |  | IVRS (LSDS) |  |  | PK
 |  |  |  | CCLS |  |  | CCSS
 |  |  |  |  |  |  | Other:
 |  | SOPs for Project |  | Sponsor |  | Covance | Other:
 |  | ECD Team Members |  | 0
 |  | Site Stdy Manager/Data PM (CVD) |  |  |  | [NAME]
 |  | Timeline |  | Target Date(s) |  | Current Date(s) |  | Actual Date(s)
 |  | [NAME] ([NAME]) |  | 2010-05-21 00:00:00
 |  | Date Drug/Device Available/Shipped
 |  | First Site Initiated |  |  |  |  |  | 2010-06-17 00:00:00
 |  | Last Site Initiated
 |  | FPFV (Screening Date) |  | #N/A |  | 2010-06-21 00:00:00
 |  | FPFV (Dose Date) |  | #N/A |  | 2010-07-21 00:00:00
 |  | [NAME] |  |  |  | 2010-08-29 00:00:00
 |  | LPLV |  | #N/A |  | 2010-09-20 00:00:00
 |  | CRFs to Data
 |  | Database Lock
 |  | Site Closeout
 |  | Safety
 |  | Medical Monitoring |  | Sponsor | Covance: |  | Other:
 |  | Physician |  | Dr Tumrick
 |  | Estimated Number of SAEs |  | unk
 |  | SAE Management |  | Sponsor | Covance: |  | Other:
 |  | Contracts
 |  | Sponsor Contract Status:
 |  | LOI/Start-up Agreement | In Progress |  | Executed | Date Executed:
 |  | Full Contract | In Progress |  | Executed | Date Executed:
 |  | Milestones |  |  |  | Date Occurred
 |  | Documents
 |  | Protocol
 |  | Synopsis/Draft |  |  | Version Date:
 |  | Final |  |  | Version Date: | 2010-05-26 00:00:00
 |  | Amendment 1 |  |  | Version Date:
 |  | Amendment 2 |  |  | Version Date:
 |  | Investigator Brochure
 |  | [NAME] |  |  | Date: |  |  | Request
 |  | Current Edition: |  |  | Date: | 2009-12-15 00:00:00
 |  | N/A |  |  | Specify Reason:
 |  | Informed Consents(Template)[i]
 |  | Main Consent |  | Approved Version Date: | 2010-06-07 00:00:00 | N/A |  | Translation Required
 |  | HIV Consent Required |  | Approved Version Date: |  | N/A |  | Translation Required
 |  | PGx Consent Required |  | Approved Version Date: | 2010-06-07 00:00:00 | N/A |  | Translation Required
 |  | Consent [NAME] by |  | Sponsor |  | Covance ECD |  | Site(s)
 |  | Site Consents Approved by |  | Sponsor |  | Covance ECD
 |  | Study Plansi
 |  | Monitoring Plan | Date Approved: |  |  | Develop |  | Review |  | N/A
 |  | CRF Conventions | Date Approved: |  |  | Develop |  | Review |  | N/A
 |  | Other Plans | Date Approved: |  |  | Develop |  | Review |  | N/A
 |  | Specify:
 |  | Site Documents
 |  | Source Documents |  |  | Date Approved: |  | Develop | Review |  | N/A
 |  | Other            (Specify: |  | ) | Date Approved: |  |  | N/A
 |  | CRFs      N/A
 |  | Review Paper CRFs/RDC |  | Generate eCRF program & edit checks |  |  | Date Approved:
 |  | Trial Master File
 |  | Sponsor |  | Covance ECD |  | Monitoring Only |  | N/A
 |  | Transfer Method to Sponsor: |  | Scanning |  | Hard Copy | UNK |  | N/A
 |  |  |  | Other (Specify:
 |  | Site/Subject Information
 |  |  |  | Target(s) |  | Current Estimate(s) |  | Actual(s)
 |  | Number of Sites Identified |  | 1 |  |  |  | 1
 |  | Number of Sites Qualified |  | NA |  |  |  | NA
 |  | Number of Sites Initiated |  | 1 |  | 1 |  | 1
 |  | Estimated Number of Screens |  | 136
 |  | Number of Subjects Randomized |  | 68
 |  | Number of Evaluable Subjects Needed/Completed |  | 68 |  | 56
 |  | Estimated Number of Data Points |  | #N/A
 |  | Estimated Number of CRFs/Subject |  | 65
 |  | Meetings
 |  | Meeting Minutes |  | Sponsor | Covance: |  | N/A
 |  | Minutes Generation
 |  | Kickoff | Target Date(s): |  | Actual Date(s): |  | N/A
 |  | ECD Participants: |  |  |  |  | Required
 |  | Teleconference / Webex
 |  | Face-to-Face (In-House)
 |  | Face-to-Face Off-Site (Location:
 |  | [NAME] | Date(s): |  |  | Trainer: |  |  | N/A
 |  | ECD Participants: |  |  |  | Required
 |  | Covance ECD Lead |  | Client Lead Face-to-Face Teleconference
 |  | Client Lead Face-to-Face In-House |  | Client Lead Face-to-Face Off-Site  (Location:
 |  | Site Status[ii] | Hold Contract with sites |  | Sponsor | Covance | N/A
 |  | Central IRB |  |  |  | Approval Date
 |  | Site | 1900-01-01 00:00:00 |  |  | Site Number
 |  | CDA Executed | Date: |  |  |  | N/A if CVD Site
 |  | Contract Executed | Date: |  |  |  | N/A
 |  | IRB Approval | Date: |  | Central IRB Date: |  | N/A
 |  | Site Enrollment:
 |  | # [NAME] |  | # Randomized |  | # [NAME] |  | # of SAEs
 |  |  |  |  |  |  |  | Date:
 |  | Reg Docs Collected | Date: |  |  | N/A
 |  | Reg Packet to Client | Date: |  |  | N/A
 |  | Monitoring |  | Sponsor |  | COVANCE |  | Third Party Vendor
 |  |  |  | Total Time for Visit incl. prep, on-site, travel, report, and follow-up |  |  |  | Time on site
 |  | Number of Site Qualification Visits (SQVs) |  | #N/A
 |  | Time for each SQV |  | #N/A |  |  |  | 0
 |  | Number of Initiation Visits (SIVs) |  | #N/A
 |  | Time for each SIV |  | #N/A |  |  |  | 8
 |  | Number of Process Monitoring Visits (PMVs) |  | 2
 |  | Observe Dose Prep |  | Yes | No |  |  | N/A
 |  | Time for each PMV |  | #N/A |  |  |  | 10
 |  | Number of Routine Monitoring Visits (RMVs) |  | #N/A
 |  | Time for each RMV |  | #N/A |  |  |  | 34
 |  | Frequency of RMVs |  | dependent upon enrollment
 |  | Number of Closeout Visits (COVs) |  | #N/A
 |  | Time for each COV |  | #N/A |  |  |  | 8
 |  | Visit Report Turn Around Time |  | 15 business days
 |  | Percentage of Source Document Verification |  | 1