1. User Guide
  2. Plan a Clinical Trial
  3. Add Your Assumptions
  4. Select Data Management Options on the Data Tab

Select Data Management Options on the Data Tab

You specify how data is to be collected and managed for your study on the Data tab of a plan.

For more information about any field, click the field name to display online help.

Parent topic: Add Your Assumptions

Specify Data Management Assumptions

Use the Data tab to specify options for collecting and managing study data.

  1. On the Plans screen, select the check box to the left of your plan, and then click the Edit button to display the Overview tab on the Edit Plan screen.
  2. Select the Data tab.

    Note:

    Many of the assumptions described below are available only in Advanced edit mode or higher.
  3. In the Data Management section, from the Data Collection Method drop-down list, select the data collection method to use for the trial.
    • Paper (Traditional Monitoring)—Monitors will visit the sites to collect data. To specify that there will be no monitoring, select this data collection method, but in the Assignments / Responsibilities section, set monitoring responsibilities to N/A.
    • Electronic Data Capture—The sponsor or a vendor added to this plan is responsible for EDC management. ClearTrial calculates associated direct labor fees and indirect costs based on the selected EDC maturity level you select from the EDC Maturity Level drop-down list. This is the default data collection method.
    • EDC - 3rd Party—Select this choice 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, also, if none of the service providers added to this plan are responsible for EDC management. You can include and assign individual tasks that are excluded by default for EDC - 3rd Party on the Assignment tab.
    • Investigator Site Data Entry—Data is keyed into a data capture system or web-based system by someone at the site. This option is not the same as EDC and was formerly known as Remote Data Entry.
  4. If you select Electronic Data Capture or EDC - 3rd Party, select the EDC Maturity Level . This drop-down list doesn't appear in Quick mode.
    • Stage 1: Pilot / Single Study—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.
    • Stage 2: Limited Standardization—You have moved past piloting EDC and have recognized its potential value. Stage 2 tests EDC abilities to full scale and assesses reliability. EDC deployment is typically expanded to other trial phases or different therapeutic areas during this stage.
    • Stage 3: Standardization—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 grand-fathered 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 entertain discussions about forming long-term partnerships with vendors.
    • Stage 4: Enterprise Deployment—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. EDC solutions found in Stage 4 provide hybrid paper/electronic features that support a limited number of paper records. All note taking is done directly in the system, and all signatures are recorded electronically. A small number of clinical trials, or certain portions of a trial, might still require the use of paper.
  5. In the Query Rate field, specify as a percentage the average number of queries expected per every 100 pages of CRF data.

    If you are planning a single treatment arm trial and have estimated in terms of queries per CRF book instead, enter the value obtained by the following conversion:

    (Number of Queries per CRF Book / Number of Pages in the CRF Book) * 100

  6. In the Percent of database data to audit field, indicate the percent of the database information that must be audited.

    Typically, the vendor who manages the data is required to audit some percentage of the database. The default for this value is 10%.

  7. In the Minutes for Data Entry per CRF page field, ClearTrial displays the number of minutes required to enter one CRF page into the database, assuming double data entry. ClearTrial calculates this value based on the phase, therapeutic area, and indication of the study. You can override this value.
  8. In the Minutes for Data Coordination per CRF page field, ClearTrial displays the number of minutes required to coordinate CRF data and calculates this value based on the phase, therapeutic area, and indication of the study. You can override this value.
  9. From time-to-time the vendor who manages the data must transfer the data in electronic format to the sponsor. This can be done at the end of the study or periodically throughout the study. In the Total number of data transfers field, enter the number of data transfers to be performed. If the sponsor is performing data management, enter 0.
  10. In the Number of interim analyses to be performed field, specify the number of interim analyses to be performed. The default value is 0 and Oracle recommends that the value should not be greater than 3.

    An interim analysis is a preliminary look at the study data to determine if there are large differences between treatment groups. Interim analyses can be planned for specified calendar times (for example, quarterly) or when specific numbers of subjects have enrolled in the study to ensure that a sufficient amount of data is available for review.

    Interim analyses typically require a dedicated monitoring trip at the end of this period to collect data so that the data can be entered into the database and the interim analysis performed. Oracle recommends that you adjust the monitoring schedule if an interim analysis is required for your study.

  11. In the Number of 3rd party vendors/data sources field, specify the number of third-party vendors or data sources used to capture study-related data. These vendors or sources are those, other than the CRO, whose data need to be imported or otherwise collected.
  12. In the Total number of data imports from 3rd party vendors field, 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. In the Number of AE coded terms field, enter the number of coded terms for adverse events in the study.
  14. In the Number of Concomitant Medication coded terms field, enter the number of coded terms for concomitant medications in the study. Concomitant medications are prescription medications, over-the-counter drugs, or dietary supplements that a clinical trial participant happens to be taking at the time of the trial in addition to the drug under investigation.
  15. In the Number of Medical History coded terms field, enter the number of codes for medical history terms.
  16. In the Number of Data Listings field, accept the default shown (one data listing per month for the months the study is conducted) or override the default value.
  17. In the Number of Unique Pages field, specify the number of Case Report Form (CRF) pages that are not duplicates of another CRF page or screen.
    For example, the same AE page that is required at each visit counts as one unique page. The minimum field value is 1.
  18. In the Number of screens per CRF page field, specify the number of screens needed to capture one paper CRF page.
  19. Continue by specifying the assumptions in the Biostatistics section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Factors for Choosing the EDC Maturity Level

Which EDC stage or maturity level you choose depends on if you have worked with that EDC vendor before for a trial.

  • If a customer or sponsor has not used an Electronic Data Capture (EDC) vendor before for any of their trials, they should select Stage 1 because it is more efficient that to start from scratch.
  • The higher the maturity level chosen, the more efficient setting up data collection is. The EDC vendor doesn’t have to rebuild data specifications and can use existing data points /schema objects from previous trials instead of starting from scratch.

Parent topic: Specify Data Management Assumptions

Specify Biostatistics Assumptions

Biostatistics is the study of data analysis and statistical reasoning applied practically to medicine and public health.

  1. On the Data tab, in the Biostatistics section, enter the number of unique and repeat tables, listings, and figures and graphs for the study.
  2. If your study is a Phase 1, Healthy Volunteers trial, complete the Unique and Repeat PK/PD sections.
    ClearTrial displays a default setting for these fields based on the number of CRF unique pages specified. You can override the estimates.
  3. Continue by specifying the assumptions in the Project Management section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Specify Project Management Assumptions

In the Project Management section of the Data Management tab, specify the media to be used to inform investigators and sponsors of overall study progress and how training is to be performed.

  1. On the Data tab, in the Project Management section, in the Number of newsletters field, indicate how many times you expect to generate newsletters for the sites. Some studies use newsletters to inform the investigators about overall study progress, compare investigators to each other, and provide updates about issues or protocol/CRF interpretation.

    For example, if there are 120 sites in a study and you enter 12 newsletters, all 120 sites are expected to receive 12 newsletters each during the enrollment and treatment period of the study.

  2. Specify whether to include an ICF video. ICF refers to the International Classification of Functioning, Disability, and Health, a framework for describing and organizing information on functioning and disability.
  3. After a study is concluded, you must archive the data for some period of time. In the Number of years to archive data field, enter the number of years. Check with your regulatory department for the most current regulations regarding data archiving.
  4. If you selected Electronic Data Capture (EDC) or EDC - 3rd Party in the Data Management section, specify the number of online EDC training sessions required.

    Note:

    This is not the training that happens at the Investigator Meeting or the initial CRA training.
  5. Continue by specifying the assumptions in the eTMF (Electronic Trial Master File) section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Specify Electronic Master Trial File (eTMF) Assumptions

These assumptions drive electronic Trial Master File indirect costs and fees estimated in a study plan budget.

  1. On the Data tab, in the eTMF (Electronic Trial Master File) section, specify the following assumptions:
    • Number of eTMF Country/Region Files - Specify the number of eTMF Country/Region files. ClearTrial defaults to one country/region file per location entered in a plan.
      This assumption value drives the defaults provided for the following tasks:
      • eTMF Country/Region File Setup
      • eTMF Country/Region File Maintenance
      • eTMF Country/Region File Close-out
      • The associated Sponsor Oversight tasks
    • Number of eTMF Site Files - Specify the number of eTMF site files.
      ClearTrial defaults to one eTMF site file per site entered in a plan. This assumption value drives the default included effort for the following tasks:
      • eTMF Site File Setup
      • eTMF Site File Maintenance
      • eTMF Site File Close-out
      • The associated Sponsor Oversight tasks, as well as the default pass-through cost
      • TMF Shipping
    • Number of months for the Vendor to archive the eTMF - Specify the number of months for the vendor to archive the eTMF.

      ClearTrial defaults this value to 12 months. This assumption's value drives the default pass-through cost for TMF Archival. If this pass-through cost is assigned to the sponsor, then it will calculate as zero.

  2. Continue by specifying the assumptions in the Medical Writing / Timelines section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Specify Medical Writing Assumptions

The medical writing assumptions you specify govern creation of an Investigator Brochure, manuscripts for industry journals, and the final study report.

  1. On the Data tab, in the Medical Writing / Timelines section, in the Number of pages in the Investigator Brochure field, specify the number of pages for the Investigator Brochure, which can be a few pages to over 250 pages.
    • The Investigator Brochure describes the drug substance or device and the formulation, a summary of the pharmacological and toxicological effects, a summary of information relating to safety and effectiveness in humans, and a description of possible risks and adverse reactions to be anticipated as well as precautions or special monitoring required.
    • You submit the brochure to investigators and, ultimately, to ethical committees for review. You can use a vendor to help write, edit, print, translate, or distribute the brochure to clinical investigators.
    • ClearTrial uses the approximate size of this brochure to calculate costs for the activities related to the production, translation, and distribution of the brochure.
    • Oracle recommends that you enter the total number of pages you expect to effectively calculate the effort required to print and distribute the brochure.
    • The default value for this field assumes that the sponsor requires that a full Investigator Brochure be written and edited for each new study.
    • If the Investigator Brochure:
      • Has been previously written, you can exclude the Write Investigator Brochure task on the Assignment tab.
      • If the brochure has been written but needs updating, include Edit Investigator Brochure on the Assignment Tab.
      • If no updates are required, exclude Edit Investigator Brochure.
  2. In the Number of manuscripts field, enter the number of manuscripts to be created for journal publication. This field must contain a value between 0 and 99.

    A manuscript is something other than the final Clinical Summary Report (CSR) and is generally a document that appears in a peer industry journal. It may be written by the sponsor, a CRO, or an independent medical writer.

  3. Set the study's primary data management cycle times if they vary from the default values displayed.

    ClearTrial's cycle time defaults are based on the study phase, data collection method, and EDC maturity level/stage. Based on the values entered for the following assumptions, ClearTrial predicts and displays the study's primary milestone dates for Database Lock, Stat Report, Draft Report, and the Final Clinical Study Report.

    • In the Days from LSLT/LPLT until Database Lock field, specify the number of estimated days from last subject last treatment until the database will be locked.
    • In the Days from Database Lock until Statistical Report due field, specify the number of estimated days from the database lock date until the statistical report is expected to be delivered. This is the time by which the assigned service provider is expected to have the statistical report completed, expressed in elapsed days from the database lock date.
    • In the Days from Database Lock until Draft Report due field, specify the number of estimated days from the database lock date until the draft clinical report is expected to be delivered. This is the time by which the assigned service provider is expected to have the draft clinical report completed, expressed in elapsed days from the database lock date.
    • In the Days from Database Lock until Final Report due field, specify the number of estimated days from the database lock date until the final clinical study report is expected to be delivered. This is the time by which the assigned service provider is expected to have the clinical summary report completed, expressed in elapsed days from the database lock date.
  4. Continue by specifying the assumptions in the End of Study section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Specify End-of-Study Assumptions

ClearTrial predicts end-of-study milestone dates such as Database Lock (EOS), Stat Report (EOS), Draft Report (EOS) and Final Report (EOS) based on the assumption values entered for these fields.

These follow-up specific milestone/timeline assumptions are displayed only if you have defined one or more treatment arms in a plan with a follow-up period.

  1. On the Data tab, in the End of Study section, in the Will there be a Supplemental CSR? field, specify if there will be another CSR to account for the data from the first follow-up visit to the study/budget end.
  2. In the Reduce effort for Supplemental CSR by field, specify the percentage to reduce the default effort included in delivering the Supplemental CSR during follow-up.
  3. In the Days from LSLV/LPLV until Database Lock (EOS) field, specify the number of days estimated from LSLV/LPLV until the Database Lock at the End-of-Study (EOS).
    This is the time (in days) from the last patient's last follow-up visit/data collection event until the Database Lock (EOS) that occurs after the follow-up or at the end of the study.
  4. In the Days from Database Lock (EOS) until Statistical Report (EOS) due field, specify the number of estimated days from the Database Lock (EOS)/End-of-Study date until the Statistical Report (EOS)/End-of-Study is expected to be delivered.
  5. In the Days from Database Lock (EOS) until Draft Report (EOS) due field, specify the number of estimated days from the Database Lock (EOS) / End-of-Study date until the Draft Clinical Report (EOS) / End-of-Study is expected to be delivered.
  6. In the Days from Database Lock (EOS) until Final Report (EOS) due field, specify the estimated days from the Database Lock (EOS) / End-of-Study date until the Final Clinical Study Report (EOS) / End-of-Study is delivered.
  7. ClearTrial determines when the costing for the planned trial will end, known as the Study/Budget End date.
    • When no treatment arms have follow-up periods defined, enter a value in the Days from Final Clinical Study Report (CSR) to Study/Budget End field. Enter 0 to stop accounting for all effort and costs at the date the final report is delivered.
    • When one or more treatment arms in a plan have a follow-up period defined, enter a value in the Days from Final CSR (EOS) to Study/Budget End field.
  8. Continue by specifying the assumptions in the Safety and Medical Management section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Specify Safety and Medical Management Assumptions

Enter your assumptions about anticipated Serious Adverse Events (SAEs) in the Safety and Medical Management section of the Data tab.

  1. On the Data tab, in the Safety and Medical Management section, in the SAE rate as a percent of randomized subjects field, estimate the number of anticipated Serious Adverse Events (SAEs) as a percent of the total subject population.
    • This value yields the expected number of SAEs across all subjects over the entire duration of the study.
    • When each subject is expected to experience multiple SAEs, this percentage can be greater than 100.
  2. In the Hours medical monitor will spend with each SAE field, specify the number of hours a medical monitor will spend with regard to each SAE.
  3. In the Expected percent of SAE Reports to be expedited field, enter the percentage of SAE reports to be expedited to regulatory agencies and ethics committees.
  4. If applicable, from the Provide data to the DSMB drop-down list, select the frequency with which to report data to the Data Safety Monitoring Board (DSMB).
  5. Continue by specifying the assumptions in the IVRS (Interactive Voice Response System section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Select Interactive Voice Response System Usage

ClearTrial uses the term IVRS for any automated system or interactive response technology (IRT) used to randomize subjects, schedule drug shipments, or maintain an online subject diary.

  1. On the Data tab, in the IVRS (Interactive Voice Response System) section, select the IVRS Usage options that identify how the Interactive Voice Response System (IVRS) will be used.
    • Randomization
    • Drug Distribution
    • Subject Diary
    • Market Study
  2. Continue by specifying the assumptions in the Expected Protocol Amendments section or click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab

Anticipate Changes to the Protocol

Updates to the protocol are common in clinical trials. You can account for anticipated changes in the form of protocol amendments added to the plan. Planning for these amendments makes the study budget more accurate.

  1. On the Data tab, in the Expected Protocol Amendments section, click the Add an amendment link.
  2. In the An amendment is expected to occur field, specify the number of days before or after a milestone the amendment is expected to occur.
    1. In the days field, enter the number of days.
    2. From the first drop-down list, select before or after.
    3. From the second drop-down list, select the milestone nearest to the date the amendment will occur.

    ClearTrial displays the anticipated amendment date to the right of the milestone drop-down to reflect this offset.

  3. To add additional protocol amendments, click the Add another amendment link and follow the instructions in Step 2.

Parent topic: Select Data Management Options on the Data Tab

Assign Responsibilities

You can identify an outsourcing option for each group of assignable tasks.

  1. On the Data tab, in the Assignments / Responsibilities section, Select a radio button to specify the outsourcing option for each group of assignable tasks. The outsourcing option (conducted Internally, Outsourced, or Combination) specified on the Overview tab, determines which options are enabled.
    • If you want all the tasks in that assignment group to be assigned to the study sponsor, choose Sponsor.
    • To initially assign all the tasks in that group to the primary provider specified on the Provider tab, select Vendor.
    • If you want to assign some of the tasks in that group to a vendor and other tasks to the study sponsor, selected Mixed. Assignments at a more granular level by task can be made on the Assignment tab.
    • If none of the tasks in that group will be performed or the service is excluded from the trial, select N/A.
  2. Click Save, and then Next to specify monitoring assumptions.

Parent topic: Select Data Management Options on the Data Tab