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Home / 2. what are some steps that could be taken to sort out the discrepancy identified in question 1?

2. what are some steps that could be taken to sort out the discrepancy identified in question 1?

4 Managing Discrepancies

A discrepancy is whatsoever data that falls outside of an expected range of values or is otherwise flagged during the edit check process as an error. Examples of a discrepancy are an invalid date, an age greater than the maximum age for the study, and inconsistent information beyond CRFs.

RDC Onsite provides several ways for you to review, resolve, and route discrepancies. This chapter includes the post-obit topics:

  • Understanding Discrepancies and the Management Process

  • Types of Discrepancies

  • Discrepancy Condition

  • Finding CRFs with Discrepancies

  • Reviewing Discrepancies

  • Resolving and Routing Discrepancies

Understanding Discrepancies and the Management Process

Discrepancy direction is the process that systematically addresses discrepancies generated within a study. Correcting and managing discrepancies ensures that the data is complete, accurate, and compliant with the report protocol.

Discrepancies Raised in the Validation Process

RDC Onsite checks and validates patient data at the following times:

  • Equally you lot enter data or when you lot save a CRF, RDC Onsite executes simple edit checks and then flags any data entry errors. You can cull to correct these discrepancies immediately during the data entry process.

  • During the patient validation process, RDC Onsite executes complex edit checks, typically relating to values that do non correlate across CRFs. You can conveniently execute patient validation after you complete the data entry for a visit.

  • If patient validation is not executed, regular nightly written report-wide batch validation raises the discrepancies that would unremarkably be defenseless by patient validation. In addition, batch validation executes edit checks that are even more circuitous and are not efficient to execute in an online session.

Manual Discrepancies Added by Users

In addition to the discrepancies that RDC Onsite generates, you lot tin place discrepancies by a visual review of the information. Users with the proper privileges tin question information in a CRF and create a transmission discrepancy for others to review.

Your Goal: Resolve All Discrepancies and Ensure Clean Data

For each discrepancy assigned to you, you must identify the cause, assess the error, and determine the appropriate action.

You can cull to immediately resolve the discrepancy as it is raised, or you tin defer the resolution for later on. In addition, you tin can road a discrepancy to another user. Your goal is to resolve all discrepancies associated with every CRF and to ensure clean data.

You use the following general procedure to manage discrepancies:

  • Search for CRFs with discrepancies

  • Open up the CRF in the Data Entry window

  • Use the tools in the Information Entry window to resolve a discrepancy, route a discrepancy, or create a manual discrepancy

Types of Discrepancies

RDC Onsite has two types of discrepancies:

  • Organisation-generated discrepancies

  • Manual discrepancies

You lot can choose to resolve discrepancies as they are raised, or you lot can defer their resolution for after.

Organisation-Generated Discrepancies

System-generated discrepancies are those discrepancies that are automatically created by RDC Onsite. These discrepancies alert you to a possible problem with a response value, or a group of response values.

Your sponsor builds edit checks into the study database. RDC Onsite executes these edit checks and raises discrepancies at diverse points in the data entry process, including when yous update data in a CRF, save a CRF, or validate a patient. In addition, RDC Onsite creates discrepancies during complex edit checks executed on a nightly basis.

In that location are ii types of system-generated discrepancies:

  • Univariate (simple)

  • Multivariate (circuitous)

Univariate Discrepancies

A univariate discrepancy, which is also called a simple discrepancy, is a discrepancy that depends on the value of a single data betoken. For example, demographics such every bit gender, age, weight, and birthdate are values with a single data point.

When you enter information into a field and and then exit from that field (by pressing the Tab central or clicking another field), RDC Onsite checks the information you entered. If the data is not valid for the field, RDC Onsite raises a univariate discrepancy. For case, if the electric current written report is for patients older than 50 years of age and you enter an historic period of 40, RDC Onsite raises a univariate discrepancy to alarm you lot to the trouble.

Univariate discrepancies typically chronicle to the format of the data entered, or to a value that does not meet pre-divers rules for the field. You can either resolve the discrepancy immediately, or let the discrepancy temporarily and resolve it later.

Multivariate Discrepancies

A multivariate discrepancy, which is also called a circuitous discrepancy, is a discrepancy that is dependent on 2 or more information points. These data points can be inside a unmarried CRF or across multiple CRFs and visits.

RDC Onsite raises multivariate discrepancies in the following cases:

  • Save a CRF. When you salvage a CRF past selecting Relieve Complete, RDC Onsite validates the patient data. If data is missing or if information does non correlate across CRFs, RDC Onsite raises a multivariate discrepancy.

  • Validate a patient. Upon completion of information entry for a visit, RDC Onsite validates the data. If values practice not correlate across CRFs, RDC Onsite raises a multivariate discrepancy.

  • Run regular batch validation. If patient data is non validated upon completion of data entry for a visit, nightly batch validation ensures that discrepancies ordinarily raised by patient validation are detected. Batch validation may also execute complex edit checks that are too time-consuming for an online session.

Manual Discrepancies

A manual discrepancy is a discrepancy that is generated by a user, rather than by RDC Onsite. You can add a transmission discrepancy to a CRF section or to a field. Yous tin can resolve discrepancies as they are raised, or defer their resolution for later.

Typically, CRAs and data managers enter manual discrepancies (or queries) and route them to site users or other user groups for a response. Investigators and other site users may also create manual discrepancies. However, to enter a manual discrepancy, y'all must exist assigned either update or update discrepancies privileges.

If y'all accept the advisable privileges, you can enter the following types of manual discrepancies:

  • Manual field discrepancies

  • Transmission section discrepancies

  • Manual internal discrepancies

Manual Field Discrepancies

You can enter a manual discrepancy in association with a specific response field in a CRF. Note that only ane manual discrepancy can be associated with a response field regardless of discrepancy status.

RDC Onsite processes manual field discrepancies every bit follows:

  • You enter a manual discrepancy against a response field in the CRF.

  • During the study, y'all resolve this transmission discrepancy.

  • In one case the manual discrepancy is resolved, RDC Onsite lets yous add together a second manual discrepancy to the aforementioned response field. When you lot save the second manual discrepancy, RDC Onsite overwrites the beginning resolved transmission discrepancy with the 2nd discrepancy because but i manual discrepancy can exist associated with a response field regardless of discrepancy status.

  • You lot can go along to enter and resolve discrepancies for the same response field. RDC Onsite overwrites the previous resolved discrepancy with the new one you add.

Note:

The discrepancy history maintains a consummate inspect for the discrepancy, even when RDC Onsite overwrites previously entered and resolved discrepancies.

Manual Section Discrepancies

You tin can enter one or more discrepancies in association with CRF sections. Y'all tin can use a section discrepancy to communicate CRF-related issues amongst site personnel, data managers, and monitors. Unlike a field discrepancy, you can acquaintance multiple discrepancies with a CRF section.

Internal Transmission Department Discrepancies

Section discrepancies can exist routed to an internal or hidden status. If your discrepancy management organisation is configured to use the hidden status, you can create a transmission section discrepancy, and route it to some other user group with an internal status. It is hidden from other user groups who demand not be involved in the communication. Typically, this is configured for utilize past various user groups internal to the sponsor or CRO, not by site users.

Discrepancy Status

The discrepancy status is a designation that describes the electric current state of a CRF with regard to discrepancies. The discrepancy condition describes the way a discrepancy appears to a user of a item role. The same discrepancy at the aforementioned betoken in time can therefore appear differently to unlike users.

RDC Onsite uses the following statuses to rail the discrepancies in a CRF:

  • Agile

  • Other

  • Hidden

  • Closed

  • None

Active and Other Discrepancies

Agile discrepancies are those discrepancies that are assigned to yous or your user function for action. Your activity may be to resolve the discrepancy or to road the discrepancy to another user for resolution.

Other discrepancies are those discrepancies that are assigned to another user role for action. A discrepancy that appears every bit Active to your user office appears as Other to another user function and vice versa.

An open status refers to CRFs that take active discrepancies, other discrepancies, or both. Open discrepancies crave action and resolution.

The status of a discrepancy changes when y'all either resolve it or route it. If y'all resolve a discrepancy, its status changes from open to closed. However, if yous but update the discrepancy, for case, by editing comments, its status does not change.

Hidden Discrepancies

A hidden discrepancy is a discrepancy that y'all cannot see because of your user role.

Closed Discrepancies

A closed discrepancy is a resolved discrepancy. To shut a discrepancy, you must specify a resolution reason that is saved as part of the discrepancy record.

A system-generated discrepancy becomes obsolete if you lot update data in conformance with the edit checks. Specifically, the discrepancy becomes obsolete whenever the edit check that originally raised the discrepancy is executed once again: upon updating the field, saving the CRF, validating the patient, or running batch validation. RDC Onsite does not display obsolete discrepancies but does maintain an inspect history for the field.

You tin manually resolve, and thereby close, both organization-generated and transmission discrepancies. Yous can resolve a discrepancy by correcting the information, updating the information, responding to a monitor'southward query, or re-confirming data veracity.

A clean status refers to CRFs that accept either no discrepancies or merely closed discrepancies (none or closed).

Colors Indicate Discrepancy Status

RDC Onsite uses color to indicate the status of discrepancies in a CRF.

For example, to alert you to an active discrepancy, RDC Onsite highlights all patient icons and CRF icons related to the item discrepancy in reddish. Similarly, to marking discrepancies with a condition of other, RDC Onsite highlights all icons in yellow.

See Table 4-1 for more information on the colors that RDC Onsite uses to point the discrepancy condition.

Table 4-1 Colors Used to Indicate Discrepancy Status

Discrepancy Category Discrepancy Status Patient Icon CRF Icon Field in the Data Entry Window

Open up

Active

Cerise

Red

Scarlet

Other

Yellow

Xanthous

Yellow

Make clean

Airtight

White

White

Green

None

Finding CRFs with Discrepancies

Your options for finding CRFs with discrepancies are:

  • Specifying Discrepancy Search Criteria

  • Using a Discrepancies Activities Link

  • Letting Colour Guide Y'all to Discrepancies

Subsequently you discover CRFs with discrepancies, you open up a CRF in the Data Entry window to take action on the discrepancies in that CRF. Your action may be to correct the discrepancy, close the discrepancy, or route the discrepancy to another user.

Notation that you tin can use the Review Discrepancies page, the Casebooks page, and the Review CRFs page to find and review the discrepancies in a CRF. However, the way in which RDC Onsite displays and groups the information about discrepancies is unlike on each page. Depending on your piece of work habits, you may accept a preference for which page you want to utilize. Run into "Reviewing Discrepancies" for more information using each page.

Specifying Discrepancy Search Criteria

You tin can use the various search criteria to find discrepancies based on their condition. The search options bachelor to you depends on the page you select.

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On the Home page, the discrepancy status is a patient-level search parameter.

On the Casebooks folio and the Review CRFs page, the discrepancy status is a CRF-level search parameter.

To notice CRFs with specific types of discrepancies, you can select the following search criteria:

  • All — Retrieves all CRFs regardless of discrepancy condition. All is the default value.

  • Active — Retrieves CRFs with any agile discrepancies; does not retrieve CRFs that have only hidden discrepancies. Active discrepancies are those discrepancies that are assigned to you or your user office for action.

  • Other — Retrieves CRFs with other discrepancies; does non call back CRFs that have merely hidden discrepancies. Other discrepancies are those discrepancies that are assigned to another user function for activity.

  • Open (Active & Other) — Retrieves CRFs with active or other discrepancies; does not retrieve CRFs that accept simply hidden discrepancies.

  • Make clean (None or Closed) — Retrieves CRFs with no discrepancies or with closed discrepancies, as well equally CRFs that accept only hidden discrepancies.

    On the Review Discrepancies page, the Clean pick is replaced past Airtight. If you select Closed, the search does non retrieve hidden closed discrepancies.

Notation:

On the Review Discrepancies page, the Agile, Other, and Open options do not retrieve hidden discrepancies.

To find CRFs that have discrepancies:

  1. Open 1 of the following pages:

    • Review Discrepancies page

    • Home page

    • Casebooks pages

    • Review CRFs page

  2. Click + to expand the Search pane. Note that the set of search fields available to you depends on the folio yous selected.

  3. Select the type of discrepancy that you desire to discover.

  4. Utilise the other search fields to specify one or more additional criteria and further restrict the search. For example, you tin can:

    • Search only for CRFs that accept a discrepancy status of active.

    • Search just for CRFs that have a discrepancy condition of active AND are in the patient range from 1 to 100.

    • Search only for CRFs that take a discrepancy status of active AND are in the patient range from 1 to 100 AND accept a CRF name of Vitals.

  5. Click Go to execute the search. RDC Onsite displays the CRFs or patients that match your search criteria.

You tin can click on any CRF to open the CRF in the Data Entry window and update the discrepancies for that CRF. See "Resolving and Routing Discrepancies" for more information.

Annotation that from the Domicile page, you first select the patients with discrepancies that yous want to review. You can and so drill downwardly to the Review Discrepancies page or the Casebooks page to open up a CRF in the Data Entry window.

Using a Discrepancies Activities Link

The Activities department on the Home page can include links to some of your common tasks. Your sponsor creates, customizes, and labels all the links in the Activities section. These links, if defined, are valuable shortcuts to your daily activities.

Your sponsor may choose to include 1 or more links to help you review discrepancies. For instance, your sponsor tin can create a Review due north Active Discrepancies link, where north represents the number of discrepancies that are your responsibility.

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Description of the illustration activities01.gif

When y'all click the Review n Active Discrepancies link, RDC Onsite automatically:

  • Executes the search that your sponsor defined when creating the link

  • Opens the Review Discrepancies folio

  • Lists all the active discrepancies across all the patients and CRFs for the electric current site

Your sponsor can name the link differently or customize links to filter discrepancies according to different criteria.

Note that later on y'all click a customized link, y'all e'er have the choice to aggrandize the Search pane and specify a smaller subset of patients or CRFs to review or update.

Letting Color Guide Y'all to Discrepancies

RDC Onsite uses colour to indicate the status of the discrepancies, if any, in a CRF. For the patient icons and the CRF icons, RDC Onsite uses:

  • Crimson to indicate active discrepancies

  • Yellow to indicate other discrepancies

  • White to indicate no discrepancies

You lot can let these colors be your guide to finding CRFs with discrepancies.

Reviewing Discrepancies

To find, order, organize, and review CRFs with discrepancies, you can utilize the Review Discrepancies page, the Casebooks page, or the Review CRFs page.

The way in which RDC Onsite displays and groups the data most discrepancies is different on each folio. Depending on your work habits, you lot may have a preference for which page you want to use.

The following sections describe the advantages and details for using each page:

  • Working with the Review Discrepancies Page

  • Using the Casebooks Page to Review Discrepancies

  • Using the Review CRFs Page to Review Discrepancies

Working with the Review Discrepancies Page

The Review Discrepancies page provides a listing of discrepancies that you tin can scroll through and sort. See Figure 4-i.

Each row contains the information for one discrepancy. If a CRF has more than one discrepancy, RDC Onsite lists each discrepancy for that CRF in its own row.

The columns brandish the following information about each discrepancy:

  • The patient number

  • The visit proper noun and date

  • The CRF proper name, the question or section in the CRF, and the response that caused the discrepancy

  • The review status for the discrepancy

  • A description of the discrepancy

The Review Discrepancies page is particularly useful for managing discrepancies because you can glance at the discrepancies across CRFs and wait for patterns. You tin can view a brief description of each discrepancy without opening the CRF.

Other advantages of using the Review Discrepancies folio to manage your discrepancies include:

  • Yous tin can sort discrepancies by any column, such as by CRF name or past description. Sorting lets you organize your work.

  • You lot tin examine the details and history of a discrepancy without opening the CRF.

  • Yous can preview discrepancies to organize them, make up one's mind priorities, and assess which ones to resolve or route.

Navigating to the Review Discrepancies Page

To navigate to the Review Discrepancies folio, you can utilise any of the following methods:

  • Select a customized action on the Domicile folio.

  • Open up the Review Discrepancies folio directly and and so search for CRFs with discrepancies.

  • Drill downward to the Review Discrepancies page with a patient selection from the Home page or the Casebooks page.

  • Drill downwardly to the Review Discrepancies page with a CRF selection from the Review CRFs folio.

Once y'all navigate to the Review Discrepancies page, you tin can:

  • Review the information displayed on the Review Discrepancies page and sort the columns before deciding on which discrepancies to accost.

  • Click a CRF icon to open the CRF in the Data Entry window and work on the selected discrepancy.

  • Click Clear to remove the current search criteria and and then re-enter a different search.

Sorting Discrepancies

Earlier yous begin to resolve or route discrepancies, you lot may want to sort the list of discrepancies to help y'all organize your work.

By default, the Review Discrepancies page lists discrepancies in ascending club by patient number. Even so, you can click any column header to sort the list by the contents of that column.

You tin can sort the listing in ascending social club or descending order. An upwardly arrow in the selected column indicates the list is sorted in ascending order; a downward arrow indicates the list is sorted in descending social club. Yous can click the same column heading to toggle between an ascending and a descending sort.

Sorting the listing may as well provide clues nigh CRF questions that often produce a discrepancy or nigh common data entry problems that need to be addressed. For example, you lot tin can:

  • Sort past Description to find any preponderance of a particular blazon of discrepancy.

  • Sort by Question/Section to see those questions that often produce a discrepancy.

  • Sort by Review Status to group discrepancies according to their electric current status.

  • Sort by Visit Date to view discrepancies by the date of the visit.

Note:

Depending on how you adopt to work or what your current task involves, limiting the search may be more than useful than sorting the columns.

For the patient number, the visit proper name, and the CRF proper name, you can sort the list of discrepancies on those columns. Alternatively, you tin enter Search criteria into the respective fields (Patient Range, Visit, and CRF Proper noun) to limit the number of discrepancies constitute.

For example, you lot tin search only for discrepancies in the CRFs for Visit 3. In this case, you would not need to sort the listing by Visit Proper name considering the listing would just include CRF discrepancies for Visit iii.

Viewing the Details of a Discrepancy

On the Review Discrepancies page, click the Particular icon in the Detail cavalcade to review any related values and a discrepancy history without having to open up the CRF. Come across Effigy 4-ii.

For multivariate discrepancies, the Review Discrepancies page also displays a MULTI link in the Question/Section cavalcade and the Response column. You can click either the MULTI link or the Detail icon to view more information about a multivariate discrepancy.

Viewing additional details is especially useful when a multivariate discrepancy involves more than than one CRF. For instance, suppose the birthdate in the Demography CRF indicates the patient is 84 years old, merely the Inclusion/Exclusion CRF indicates the patient is between 30 and 55 years. The discrepancy appears for the primary CRF, which is the Inclusion/Exclusion CRF in this example.

To view details and then take action on a multivariate discrepancy:

  1. Open up the Review Discrepancies page.

  2. Sort past Clarification to find a group of the same blazon of multivariate discrepancy.

  3. Select the Detail icon for a discrepancy.

  4. Review the Related Values section of the Discrepancy Details pane. This section lists the CRFs involved with the discrepancy.

    The Related Values department does non display entries for related values from any CRFs that are subconscious based on your user role.

  5. Select ane CRF icon after the other, to view both the contributing CRFs in adjacent windows. Decide on your course of action, perhaps updating data in one or the other of the CRFs.

Discrepancies and Extended Text Fields

You lot can add discrepancies to an extended text field. However, discrepancy listings for such fields exercise not brandish the complete extended text. Instead, a discrepancy listing displays the ATTACHMENT prefix followed by a truncated response text. The system reserves 24 characters of the defined field length for the Attachment prefix.

Therefore, the number of characters in the truncated response text is calculated as follows:

Characters in Truncated Reponse Text = Defined Field Length – 24

Extended text fields back up the following types of discrepancies:

  • Transmission discrepancies.

  • Multivariate discrepancies. Note that RDC Onsite runs this confronting the truncated response text, not the complete extended text.

  • Hidden discrepancies.

In the Discrepancies Details pane, y'all can view only the ATTACHMENT prefix and the truncated response text.

Using the Casebooks Page to Review Discrepancies

The Casebooks page organizes CRF icons in patient rows and CRF columns in casebook order. This organization tin exist useful in finding discrepancies on a patient-by-patient or visit-by-visit footing.

Managing discrepancies from the Casebooks page has some other reward. When you open a CRF from the Casebooks page, the Next CRF and Previous CRF links are available in the Data Entry window. Y'all tin can employ these links to wheel through the CRFs and discrepancies for the selected patient, without having to return to the Casebooks folio.

Using a Filtered Casebook Spreadsheet View

When you use the Next CRF and Previous CRF links along with search criteria, you can filter the casebook and display only the CRFs needed for your work. For example, you can search for and display but CRFs with active discrepancies.

In this case, clicking the Adjacent CRF link in the Data Entry window navigates but to the CRFs with agile discrepancies, skipping empty CRFs and CRFs with no active discrepancies, without having to return to the Casebooks folio.

Furthermore, the Casebooks folio displays only those CRFs that have active discrepancies for the filtered patients, resulting in a sparsely populated spreadsheet. For this case, the Casebook spreadsheet:

  • Displays all ruby CRF icons. (Icons are red considering of the Active discrepancy search criteria. The display changes based on the specified search criteria.)

  • Does not display CRF icons where data is expected, or where information has been entered, only the CRF has no active discrepancies.

Using a Non-filtered Casebook Spreadsheet View

If you prefer to see CRF icons for all entered data, select All in the Discrepancy field in the Search pane. When you lot execute the search, RDC Onsite refreshes the spreadsheet on the Casebooks page. The spreadsheet still displays just patients with discrepancies, but you see all entered CRFs for those patients, with or without discrepancies. You lot can and so select any CRF icon to open up it in the Information Entry window and accept action on the discrepancies.

Using the Review CRFs Page to Review Discrepancies

The Review CRFs page displays CRFs with discrepancies in a list format that you can scroll through and sort.

Similar to the Casebooks page, you tin can employ the Review CRFs page to identify all CRFs with discrepancies. The Review CRFs folio provides boosted information about each CRF, including the dates on which the CRF was last modified, verified, approved, and locked. You can sort the CRF list by whatsoever of the date fields. For example, sort by the Modified Appointment to work on the oldest CRFs get-go.

Tip:

Select the Show Timestamps bank check box to view time stamps in the date fields.

Resolving and Routing Discrepancies

After you search for and identify CRFs with discrepancies, you tin can click a CRF icon to open the CRF in a Data Entry window and take activity on a discrepancy. While the Data Entry window is open, y'all tin decide to work on 1, some, or all the discrepancies for that CRF.

Topics in this department include:

  • Highlighting the Discrepancies in a CRF

  • Reviewing Discrepancies in the Navigator Pane

  • Taking Action on Discrepancies

  • Creating and Routing Manual Discrepancies

Highlighting the Discrepancies in a CRF

The Information Entry window uses the post-obit colors to highlight the different types discrepancies in a CRF:

  • Red highlights fields with active discrepancies

  • Yellow highlights fields with other discrepancies

  • Dark-green highlights fields with closed (manually resolved) discrepancies

Annotation:

RDC Onsite highlights fields according to the discrepancy that takes precedence. If a field has various discrepancies, so active discrepancies take precedence over other and airtight discrepancies, and other discrepancies accept precedence over airtight discrepancies. For case, if a field has both active and other discrepancies, and then RDC Onsite highlights the field in red.

In addition, RDC Onsite does not highlight fields that have but subconscious discrepancies.

To highlight the fields that have one or more discrepancies:

  1. Click Highlight in the toolbar in the Data Entry window.

    Description of dew_highlight01.gif follows
    Description of the illustration dew_highlight01.gif

  2. Select an choice from the list. Your options for highlighting discrepancies are:

    • Active Discrepancies — Highlights all fields associated with agile discrepancies in red. Agile discrepancies require activeness past your user function or group.

    • Agile and Other Discrepancies — Highlights all fields associated with active discrepancies in ruddy and all fields associated with other discrepancies in yellowish. Other discrepancies require activeness by some other user role or grouping.

    • Closed Discrepancies — Highlights all fields associated with a manually resolved (user airtight) discrepancy in green.

    • All Discrepancies — Highlights all fields associated with active, other, and closed discrepancies in their respective colors (red, yellowish, and green).

    • None — Highlights no fields.

Reviewing Discrepancies in the Navigator Pane

The Navigator pane, shown in Figure 4-3, displays on the right side of the Data Entry window. You use the Navigator pane to review, in list format, all discrepancies for a CRF. As you navigate through the listing of discrepancies, the cursor simultaneously navigates through the associated fields in the CRF.

Opening, Closing, and Resizing the Navigator Pane

  • To open the Navigator pane, click the arrow on the right edge of the Data Entry window.

  • To close Navigator pane, click the arrow on its left edge.

  • To resize the Navigator pane, drag the vertical and horizontal splitter bars to adjust the width and length of the opened pane.

Showing and Selecting Discrepancies in the Navigator Pane

Yous can utilise the List and Details panes in the Navigator to review, highlight, and update particular discrepancies in a CRF.

To use the Navigator pane to display and review discrepancies:

  1. Click the Show field and select a filter from the list. You can select to show:

    • Active Discrepancies

    • Agile and Other Discrepancies

    • Closed Discrepancies

    • All Discrepancies

    Based on your filter selection, the List pane displays the discrepancies for the electric current CRF. Note that:

    • Discrepancies associated with multiple fields display as Multi.

    • Hidden discrepancies exercise not display regardless of the filter y'all select.

    • The total count displayed in the Navigator pane does not include subconscious discrepancies.

  2. Select the discrepancy y'all desire to work with from the list. Annotation that:

    • The Details pane refreshes and displays more than information near the discrepancy.

    • The discrepancy you selected in the List pane is highlighted in blue, and the associated field (or fields if multiple fields are associated with the discrepancy) in the CRF is outlined with a blue dashed line.

    • If you also selected a Highlight choice, then the discrepant field is additionally highlighted.

For long lists, use the curl bar to view additional information in the List pane. In addition, click the + or - icon in the championship bar to aggrandize or collapse the pane.

Reviewing Discrepancy Data in the Details Pane

One time y'all select a discrepancy in the List pane of the Navigator, the Details pane displays additional information nearly the selected discrepancy.

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The information, which varies depending on the current status of the discrepancy and on how your sponsor customized RDC Onsite, can include:

  • Description — A description of the discrepancy.

  • Type — The type of discrepancy, for example, manual or univariate.

  • Created By — The proper noun of the user who created the discrepancy. If this is a manual field or section discrepancy, the user function is included after the user proper noun.

    Notation that this entry displays the name of the user who created the discrepancy. For the proper name of the user who final updated the discrepancy, click History to view the Discrepancy History dialog box.

  • Review Status — The current review condition of the discrepancy.

  • Reason — The reason for the discrepancy. Note that the reason does non display if this is a multivariate discrepancy.

  • Comment — Additional annotate information, if entered when creating the discrepancy.

  • Resolution — The resolution reason and the resolution comment, if the discrepancy was closed.

  • Last Updated — The date and fourth dimension the discrepancy was last updated.

  • Discrepancy ID — The ID for the discrepancy. This information displays just if your sponsor customized RDC Onsite to include the ID.

If necessary, use the scroll bars to view boosted information in the Details pane. In addition, click the + or - icon in the title bar to expand or collapse the pane.

Viewing the History of a Discrepancy

Click the History push in the Details pane to view the history of the currently selected discrepancy.

The Discrepancy History dialog box displays the Date, Description, Updated by, Review Status, Comment, Resolution Reason, and Resolution Comment.

Viewing Related Values for Multivariate Discrepancies

A multivariate discrepancy is a discrepancy that is dependent on two or more information points, or values. These data values tin can be inside a single CRF or across multiple CRFs and visits.

When you select a multivariate discrepancy, you tin click the Related Values button in the Details pane to list all reported values associated with the multivariate discrepancy.

For each value, the Related Values dialog box displays the CRF Name, the Visit, and the Question/Variable.

The Question/Variable column displays either the Question name or the Validation Process variable proper name associated with the discrepancy. A Validation Procedure variable is a calculated value. The variable might be used to process a validation bank check or to provide relevant data for discrepancy review.

For repeating groups, the Row Number displays in parenthesis next to the Question/Variable name.

Reviewing the Audit History for a Discrepancy

If the discrepancy you selected in the Navigator pane has an audit history, you can view the audit trail by opening the Inspect History pane at the bottom of the Data Entry window.

If a selected discrepancy is associated with multiple fields in the CRF (as with multivariate discrepancies), then the Audit History pane displays no data.

Updating Discrepancy Comments

Description of icon_upd_discrep.gif follows
Description of the illustration icon_upd_discrep.gif

While reviewing a discrepancy in the Data Entry window, you can update its associated annotate.

To update a discrepancy comment:

  1. Open the Navigator pane.

  2. Click the Discrepancy tab.

  3. Select the discrepancy you want to piece of work with from those shown in the List pane.

  4. Click the Update icon. The Update Discrepancy dialog box opens.

  5. Update the comment with your changes. In addition, you can update the discrepancy description in the following situations:

    • If the discrepancy is either a manual field discrepancy or a manual section discrepancy, y'all can modify the description text by typing in the field. Yous tin can enter upward to 2000 characters. When you click OK, RDC Onsite verifies the number of characters in the field. If you entered more than than 2000 characters, RDC Onsite forces yous shorten the description before continuing.

    • If the discrepancy is a system-generated discrepancy and more than than one standard text exists for the category and type of discrepancy, yous tin select from a list of values containing the standard text.

  6. Click OK to salve your changes.

Taking Action on Discrepancies

You can apply the Navigator pane in the Information Entry window to take action on the accumulated discrepancies for a CRF. These discrepancies include those raised during the validation process, also equally queries manually raised by monitors and data managers too using RDC Onsite.

Types of Discrepancy Actions

There are 2 types of discrepancy actions: routing and resolution.

Routing actions assign the discrepancy to the members of another user group (that is, users with a certain role). For case, the Send to site activeness assigns the discrepancy to the Site user role. When y'all road a discrepancy, you can include a comment that RDC Onsite saves with the discrepancy.

In contrast, resolution deportment immediately close the discrepancy. When you lot close a discrepancy, y'all must provide a resolution reason. In addition, you can enter a resolution comment.

Past default, RDC Onsite provides the post-obit standard routing and resolution deportment that yous can take to procedure a discrepancy:

  • Send to site

  • Send for classification

  • Closed - resolved

  • Closed - no resolution

However, your sponsor can customize and rename these default actions, assign the actions to particular user roles, and add other discrepancy actions.

Acting on Active versus Other Discrepancies

Open up discrepancies require action and resolution. An open discrepancy tin can accept a condition of active or other.

By default, RDC Onsite does not forbid you from taking activeness against any open discrepancy, regardless of whether the status is active or other.

Your sponsor, however, tin can customize RDC Onsite so you lot can only accept action on active discrepancies. In this case, you lot can view discrepancies with a status of other, but you lot cannot route or resolve these discrepancies.

Routing Discrepancies

You alert a different user group (users with a certain part) to the presence of a discrepancy by routing it. Routing causes discrepancy status to alter from active to other. If the advisable highlight pick is chosen, RDC Onsite so highlights the associated other discrepancy icons in yellow.

To road a discrepancy:

  1. Click a CRF icon to open up it in the Information Entry window.

  2. Open up the Navigator pane and select a discrepancy from the listing.

  3. Click the Action field and select an action from the list.

    The bachelor actions are specific to your role. For example, a CRA tin can send a discrepancy to site (Send to Site) or to a director (Send to Data Manager).

  4. Click Go. A Discrepancy Activeness dialog box opens and displays your selected action in its championship. The Review Status displays the future selected status of the discrepancy.

  5. Modify, if required, the description of a user-entered discrepancy, or select a value from the list, if available.

  6. Enter a Comment if yous want, explaining why the discrepancy is being routed.

  7. Click OK to route the discrepancy.

If you route a discrepancy to a hidden status, RDC Onsite removes it from the listing and the discrepancy is no longer visible.

Resolving Discrepancies

As y'all employ the Data Entry window and its Navigator pane to review discrepancies, yous may notice discrepancies that you tin can resolve.

To resolve a discrepancy:

  1. Click a CRF icon to open it in the Data Entry window.

  2. Open the Navigator pane and select a discrepancy from the listing.

  3. Click the Action field and so select an action to shut or resolve the discrepancy. Actions are appropriate and specific to your role.

  4. Click Go. A Discrepancy Action dialog box opens and displays your selected action in its title. The Review Status displays the future selected condition of the discrepancy, for example, RESOLVED.

    Description of closediscrep.gif follows
    Clarification of the illustration closediscrep.gif

  5. Click the Resolution Reason field and select a reason from the list. If no default values be, the list is empty. You lot must enter a resolution reason into this mandatory field.

  6. Enter a annotate in the Resolution Comment text box if you want to provide more information about why y'all are resolving the discrepancy.

  7. Select the check box if you lot desire RDC Onsite to remember your comment for subsequent use. Select this selection merely if yous intend to reuse the aforementioned comment.

  8. Click OK to resolve the discrepancy.

When you resolve a discrepancy, RDC Onsite changes the colour of its associated icons to light-green, if the appropriate highlighting selection is selected. Afterward yous resolve or close a discrepancy, information technology cannot exist updated nor can you perform whatsoever activeness on it.

Note:

RDC Onsite remembers the Resolution Reason y'all specified and the Resolution Annotate you entered (provided you selected the remember comment cheque box), until you:

  • Enter a different reason or annotate

  • Change your study

  • Log out of RDC Onsite

Creating and Routing Transmission Discrepancies

With the appropriate privileges, you lot can create a manual discrepancy for a response field or a CRF department.

You can create just one manual discrepancy for a field in a CRF.

Note that if a field has an existing manual discrepancy and the review status is Closed, then you can create a new transmission discrepancy on the field. In this case, RDC Onsite re-opens the existing manual discrepancy.

However, if whatsoever of the following weather be, RDC Onsite grays out the Field Discrepancy pick in the Add Discrepancy dialog box:

  • If a not-closed transmission discrepancy already exists on a field, you cannot create another manual discrepancy on the same field. Y'all can view the existing discrepancy, but you cannot create a new manual discrepancy.

  • If a hidden, non-closed manual discrepancy exists on a field, you cannot create some other transmission discrepancy on the same field. In this case, you cannot see the hidden manual discrepancy associated with the field.

  • If your user part has update discrepancy privileges just and the CRF is non Laissez passer 1 consummate, you cannot create a manual discrepancy.

To create and route a manual discrepancy:

  1. Open the CRF in the Data Entry window.

    • To add a manual discrepancy to a field, select the field.

    • To add a manual discrepancy to a department, either select a response field in the department or click the section discrepancy bar to select the section.

  2. Click the Add Discrepancy icon in the toolbar. Alternatively, you can right-click the field and then select Add together Discrepancy from the menu.

    Description of adddiscrep.gif follows
    Description of the illustration adddiscrep.gif

  3. Select Field Discrepancy or Section Discrepancy depending on the type of manual discrepancy you are adding.

  4. Click the Reason field and so select a reason from the list. You must specify the reason why you lot are entering this manual discrepancy. A reason is mandatory.

  5. Enter a Description of the discrepancy in the text field.

  6. Enter a Annotate if y'all desire.

  7. Click the Activity field and then select an option for routing the discrepancy for review, if you want. Your selection is reflected in the Review Condition field.

  8. Click OK to add the discrepancy.

    If the highlight option is selected, RDC Onsite highlights the field discrepancy in the CRF, in cherry, if non routed afterward initiation.

    • If you lot click Highlight in the toolbar and select All Discrepancies, the RDC Onsite highlights the discrepancy in the CRF co-ordinate to its current status.

    • If you click the Show field in the Navigator pane and select All Discrepancies, the List pane displays and highlights the discrepancy co-ordinate to its electric current condition.

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Source: https://docs.oracle.com/cd/E18667_02/doc.46/b31158/managing.htm