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Zapatec AJAX Forms

Requestor Information
Requestor Name:

Requestor UNIX ID:

Name of DOC Outsourcing Lead:

Study Information
Protocol #:

Study Phase:

I, II or III
IV or Registry
No Phase

Study Information (continued)
Study Name (if applicable):

Molecule:

Indication:

Study Location:
(Check all that apply)

U.S.
Canada
Mexico
Central America
South America

Europe
Middle East
Africa
Asia
Australia

Participating Service Provider Information
Company Name:

Service Type:

Click (+) to add other participating service providers.

User Access - Company Staff
UNIX ID:

User Role Type:

Access action:
(for study identified above)

Click (+) to add other participating Company staff members.

User Access - Service Provider Staff
Service Type:

Company Name:

User’s Name:

User’s Email:

User’s Work Phone number:

Access action:

Click (+) to add other participating service provider staff members.

Study Management Strategy

Will the Company clinical site management (CSM) organization be responsible for any component of site monitoring on this study? Yes No

Please designate which performance metrics will be collected for each applicable service provider.
The metrics are listed below, according to service type.

CRO - Setting Up Metrics for Performance Data Collection

+ Click to expand

1.1 (Contracting metric) Time from “Award of Work” to “Initial Exhibit (signed off by all parties)”

Are you collecting data for this metric? Yes No

Please explain:

1.2 (Contracting metric) Percent Variance on Labor Budget Resulting from “Remedial Change Orders”

Are you collecting data for this metric? Yes No

Please explain:

2.1a (Enrollment metric, including start-up) Time from “Protocol Final” to FPI

Are you collecting data for this metric? Yes No

Please explain:

2.1b (Enrollment metric, including start-up) Proportion of Sites Activated by FPI: are you collecting data for this metrics?

Are you collecting data for this metric? Yes No

Please explain:

2.5a (Enrollment metric, including start-up) Enrollment (# of patients) Compared to GNE-defined Target Numbers at Defined Time Points

Are you collecting data for this metric? Yes No

Please explain:

2.5b (Enrollment metric, including start-up) Enrollment Projections

Are you collecting data for this metric? Yes No

Please explain:

2.6 (Enrollment metric, including start-up) “Time to complete enrollment” Compared to GNE-defined Target Time

Are you collecting data for this metric? Yes No

Please explain:

3.1 (Monitoring metric) Proportion of sites achieving GNE-defined Target Time From “First Patient Enrolled at Site” to “First Monitoring Visit”

Are you collecting data for this metric? Yes No

Please explain:

3.2 (Monitoring metric) Proportion of final monitoring reports submitted within the GNE-defined target time for submitting monitoring reports

Are you collecting data for this metric? Yes No

Please explain:

3.3 (Monitoring metric) Proportion of monitored CRFs submitted within GNE-defined target time

Are you collecting data for this metric? Yes No

Please explain:

3.4 (Monitoring metric) Proportion of deviations and exemptions closed by subsequent monitoring visit

Are you collecting data for this metric? Yes No

Please explain:

3.5 (Monitoring metric) Proportion of queries closed in GNE-defined target time

Are you collecting data for this metric? Yes No

Please explain:

*Metric 3.5 follow-up: Is your study using Company’s Oracle Clinical database for data collection?

Yes No

(If “no,” this metric is not applicable to your study and data will not be collected)

4.1 (Data Management metric) Time from “Edit Check” to “Query Sent Out”

Are you collecting data for this metric? Yes No

Please explain:

*Metric 4.1 follow-up: Is your study using Company’s Oracle Clinical database for data collection?

Yes No

(If “no,” this metric is not applicable to your study and data will not be collected)

4.2 (Data Management metric) Proportion of “Queries Raised from Edit Checks” sent out within the GNE-defined target time

Are you collecting data for this metric? Yes No

Please explain:

*Metric 4.2 follow-up: Is your study using Company's Oracle Clinical database for data collection?

Yes No

(If “no,” this metric is not applicable to your study and data will not be collected)

4.3a (Data Management metric) Variance from GNE-defined target time for “Event” to “Decision DB Lock”

Are you collecting data for this metric? Yes No

Please explain:

4.3b (Data Management metric) Time from “LPO” to “Administrative DB Lock”

Are you collecting data for this metric? Yes No

Please explain:

Central Lab - Setting Up Metrics for Performance Data Collection

+ Click to expand

1.1 (Contracting metric) Time from “Award of Work” to “Initial Exhibit (signed off by all parties)”

Are you collecting data for this metric? Yes No

Please explain:

1.2 (Contracting metric) Percent Variance on Labor Budget Resulting from “Remedial Change Orders”

Are you collecting data for this metric? Yes No

Please explain:

2.4 (Lab metric) Proportion of “complete and usable laboratory kits” on site within GNE-defined target time

Are you collecting data for this metric? Yes No

Please explain:

3.9a (Lab metric) Time from “Central Lab notified of Error (within their control) by Company” to “Error Corrected by Central Lab”

Are you collecting data for this metric? Yes No

Please explain:

3.9b (Lab metric) Number of errors within Central Lab control that are identified by Company

Are you collecting data for this metric? Yes No

Please explain:

3.10 (Lab metric) Proportion of agreed test performed by the Central lab

Are you collecting data for this metric? Yes No

Please explain:

IVRS - Setting Up Metrics for Performance Data Collection

+ Click to expand

1.1 (Contracting metric) Time from “Award of Work” to “Initial Exhibit (signed off by all parties)”

Are you collecting data for this metric? Yes No

Please explain:

1.2 (Contracting metric) Percent Variance on Labor Budget Resulting from “Remedial Change Orders”

Are you collecting data for this metric? Yes No

Please explain:

2.2 (IVRS metric) Time from “Final IVRS SRD” to “IVRS Live”

Are you collecting data for this metric? Yes No

Please explain:

3.6 (IVRS metric) Time to implement agreed changes to IVRS post go-live compared to GNE-defined target time

Are you collecting data for this metric? Yes No

Please explain:

3.7 (IVRS metric) “IVRS up-time” as a proportion of total time IVRS required

Are you collecting data for this metric? Yes No

Please explain:

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Page last modified on Thursday, March 18, 2010 @ 01:10 pm – One Love.