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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.0 E36710-02 |
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# 13 Data Tab

The Data Tab is used to specify information regarding the collection and management of study data.

## 13.1 Data Collection

The Data Tab allows you to indicate how data will be collected by selecting a data collection method.

### 13.1.1 Data Collection Method

The Data Collection Method selected on the Data Tab determines which pieces of data need to be collected and managed. If there will be no monitoring for the study, select “Paper (Traditional Monitoring)” and set monitoring responsibilities to N/A.

The Data Collection Methods include:

1. Paper (Traditional Monitoring): Select this method if monitors will visit the sites to collect data.

2. Electronic Data Capture (EDC): Select this method if a Sponsor, CRO or other provider added to this plan is responsible for EDC management. ClearTrial will calculate associated direct labor fees and indirect costs based on the level of EDC proficiency.

3. EDC-3rd Party: Select this method only if you do not want ClearTrial to calculate labor fees related to EDC, but instead want to create or adjust pass through costs to account for these expenditures. Use this option if none of the providers added to this plan are responsible for EDC management. Use the Assignment Tab to include and assign individual tasks that have been excluded by default for EDC 3rd Party.

4. Faxed CRFs: Select this method if the Case Report Forms (CRFs) will be completed at the Investigator Site and faxed to the CRO, or to the location where data management is performed.

5. Investigator Site Data Entry: Select this method if data will be keyed into a data capture system or web-based system by someone at the site. (Note: This option is not the same as EDC and was formerly known as Remote Data Entry.)

### 13.1.2 EDC Maturity Level

If “Electronic Data Capture (EDC)” is selected as the data collection method, then the EDC Maturity Level field will become available. This field allows you to specify the level of EDC proficiency for a study.

The default value for this field is Stage 1 for “Electronic Data Capture (EDC)” and Stage 4 for “EDC- 3rd Party.” Stage 1 represents the least level of proficiency and Stage 4 indicates expert level. Effort, costs, and study duration will be greater for lower levels of proficiency. Each option is explained below:

- Stage 1: Pilot/Single Study: Select Pilot/Single Study if you are actively conducting experimental EDC implementations within a single study or within a very limited number of clinical trials. The primary goal in conducting pilot or single-study EDC implementations is to identify the possible benefits achievable for you.

- Stage 2: Limited Standardization: Select Limited Standardization if you have moved past piloting EDC and have recognized its potential value. Stage 2 is used to test EDC abilities to full scale and to assess its reliability. EDC deployment is typically expanded to other trial phases or different therapeutic areas during this stage.

- Stage 3: Standardization: Select Standardization if you have an established standardization for EDC on all new trials over all phases and therapeutic areas. Most clinical trials using paper are doing so only because they began prior to initial EDC implementation and are grandfathered until they conclude. There is a high level of integration between EDC and other systems such as CTMS, laboratory systems, project management systems, payment systems, and IVRS. During this stage, companies commit to a preferred EDC solution vendor and willingly entertain discussions about forming long-term partnerships with vendors.

- Stage 4: Enterprise Deployment: Select Enterprise Deployment if you have an established enterprise-wide standardization on a single integrated EDC solution and all clinical management systems are fully integrated with the EDC system. All note taking is done directly in the system, and all signatures are done electronically. A small number of clinical trials, or certain portions of a trial, may still require the use of paper. EDC solutions found in Stage 4 provide hybrid paper/electronic features that support a limited number of paper records.

### 13.1.3 Query Rate

This field allows you to specify the average number of queries expected per every 100 pages of CRF data.

### 13.1.4 Percent of database data to audit

This field allows you to indicate what percent of the database information must be audited. The default value for this field is 10%, however, you may override this value.

### 13.1.5 Minutes for data entry per CRF page

This field displays the number of minutes required to enter one CRF into the database and assumes double data entry. This value is calculated based on the phase and therapeutic indication of the study. You can override this value.

### 13.1.6 Minutes for data coordination per CRF page

This field displays the number of minutes required to coordinate CRF data. This value is calculated based on the phase and therapeutic indication of the study. You can override this value.

### 13.1.7 Total number of data transfers

This field allows you to specify the number of data transfers expected. The vendor who manages the data will be required to transfer the data in electronic format to the Sponsor. If the Sponsor is performing data management, enter 0.

### 13.1.8 Number of interim analyses to be performed

This field allows you to specify the number of interim analyses to be performed. An interim analysis is a preliminary look at the study data to determine if there are large differences between treatment groups.

### 13.1.9 Number of third-party vendors/data sources

This field allows you to specify the number of third-party vendors or data sources used to capture study-related data.

### 13.1.10 Total number of data imports from third-party vendors

This field allows you to specify the total number of imports from third-party vendors expected throughout the study. This is the total number of imports, not the number expected per third-party vendor.

## 13.2 CRF Design

The Data Tab allows you to enter details about the Case Report Forms (CRFs).

### 13.2.1 Number of unique pages

This field allows you to enter the number of unique pages in the Case Report Form (CRF) that are not duplicates for another CRF page/screen.

### 13.2.2 CRF page NCR ply

This field allows you to specify the number of screens needed to capture one paper Case Report Form (CRF) page.

### 13.2.3 Number of screens per CRF Page

This field allows you to specify the number of screens needed to capture one paper Case Report Form (CRF) page when either Electronic Data Capture or EDC - 3rd Party is selected as the Data Collection Method.

### 13.2.4 Cost per page to print CRF

This field allows you to specify the cost to print a Case Report Form (CRF) page. The costs for printing a CRF page are dependent on the number of NCR plies of the CRF page and the binding method.

## 13.3 Biostatistics

The Data Tab allows you to enter specifics about data based on biostatistics for the study.

### 13.3.1 Number of unique data tables

This field allows you to enter the number of unique tables, based on biostatistics estimates in support of the study.

### 13.3.2 Number of unique data listings

This field allows you to enter the number of unique data listings, based on biostatistic estimates for the study.

### 13.3.3 Number of unique figures and graphs

This field allows you to enter the number of unique figures or graphs, based on biostatistics estimates for the study.

## 13.4 Project Management

The Data Tab allows you to enter specifics about project management.

### 13.4.1 Number of newsletters per site

This field allows to you indicate the number of newsletters expected per site.

### 13.4.2 Will there be an ICF Video/DVD?

This field allows you specify whether there will be an ICF Video.

### 13.4.3 Number of years to archive data

This field allows you specify the number of years the study data must be kept after completion of the study. After a study is concluded, the data are required to be archived for some period of time.

### 13.4.4 Number of online EDC training sessions

This field allows you to specify the number of online EDC training sessions that will be required, if you selected "Electronic Data Capture (EDC)" or "EDC - 3rd Party" as the data collection method.

## 13.5 Medical Writing / Timelines

The Data Tab allows you to specify details about medical writing and timelines.

### 13.5.1 Number of pages in the Investigator brochure

This field allows you to enter the number of pages expected to be in the Investigators Brochure (IB).

### 13.5.2 Number of manuscripts

This field allows you specify the number of manuscripts to be created.

### 13.5.3 Days from LSO/LPO until database lock

This field allows you to enter the number of elapsed days from last subject observation (LSO/LPO) until the expected database lock.

### 13.5.4 Days from database lock until statistical report is due

This field allows you to enter the number of elapsed days from the database lock date until the statistical report is expected to be delivered.

### 13.5.5 Days from database lock until draft report is due

This field allows you to enter the number of elapsed days from the database lock date until the draft clinical report is expected to be delivered.

### 13.5.6 Days from database lock until final report is due

This field allows you to enter the number of elapsed days from the database lock date until the final clinical summary report (CSR) is expected to be delivered. This is the time by which the assigned service provider is expected to have the CSR completed, expressed in elapsed days from the database lock date.

If you selected "Electronic Data Capture (EDC)" or "EDC - 3rd Party" as the data collection method, the default value will be calculated based on the EDC maturity level.

## 13.6 SAE Management

The Data Tab allows you to specify information about SAE Management.

### 13.6.1 SAE rate as a percent of randomized subjects

This field allows you to indicate the number of anticipated Serious Adverse Events (SAEs) in terms of a percent of the total subject population.

### 13.6.2 Hours medical monitor will spend with each SAE

This field allows you specify the number of hours a medical monitor will spend with regard to each Serious Adverse Event (SAE).

### 13.6.3 Expected percent of SAE reports to be expedited

This field allows you to enter the expected percentage of SAE reports to be expedited to regulatory agencies and ethics committees.

### 13.6.4 Provide data to the DSMB

This field allows you indicate how often data will be reported to the Data Safety Monitory Board (DSMB).

## 13.7 IVRS (Interactive Voice Response System

The Data Tab allows you to enter specifics about how an IVRS will be used.

## 13.8 Responsibilities

The Responsibilities section includes radio buttons that allow you to indicate the outsourcing option for each group of assignable tasks. The outsourcing options include:

- Sponsor: Assigns all of the tasks in that group to the study sponsor.

- Vendor: Initially assigns all of the tasks in that group to the Primary Vendor specified on the Provider Tab.

- Mixed: Indicates that you would like to assign some of the tasks in that group to a vendor and other tasks in that group to the study sponsor; this can be done on the Assignment Tab.

- N/A: Indicates that none of the tasks in that group will be performed, if they are optional.

If you have selected “Conducted Internally” on the Overview Tab, you will not be able to assign any of the responsibilities to Vendor. Similarly, if you have selected “Outsourced” on the Overview Tab, you will not be able to assign any of the responsibilities to Sponsor.

If you determine that you want a combination of some responsibilities assigned to the Sponsor and some assigned to a Vendor, then change your selection on the Overview Tab to “Combination.”