what is annotated crf

12 Annotating CRFs

As part of your internal processes and/or a component of a regulatory submission, you may find it necessary to annotate the CRFs you use in a protocol. Oracle Clinical provides the capability to create an annotated CRF from a DCI graphical layout via the Graphic Layout Editor (GLE). The annotated CRF that you create in Oracle Clinical uses the names of the fields you setup in the GLE, as well as any other attributes you specify. The annotations are either located adjacent to each field or else a number is used to associate each field with its annotation in a footnote. Because this process is automatically generated and extensively customizable, the process of annotating your CRFs using Oracle Clinical is can be integrated into your normal CRF design workflow.

This section discusses where in your CRF design workflow you may find it advantageous to generate annotated CRFs, describes the procedures you use to create them, and defines the tools you use in these procedures.

This section consists of the following topics:

Using the CRF Annotation Tool Window

Although you can use an FLT or DCM block layout to create an annotated form at any time during the CRF design process in order to aid your internal mapping and/or auditing procedures, the primary purpose of creating an annotated CRF in OC/RDC is for inclusion in regulatory submissions. For this usage, you start with a DCI form layout. Oracle recommends that you create an annotated CRF for each version of a DCI form layout you use and, if you modify a form during a study, that you create an updated annotated CRF for that form.

Note that the process of creating an annotated form from a DCM Block layout or an FLT layout is identical to that described for the annotated CRF.

The process of creating an annotated CRF is straightforward. When the DCI graphical layout is finalized, you use the GLE to create an "annotation-ready" PDF of the layout and open it in the PDF DEW. When you open this file in the PDF DEW, the system recognizes that it is annotation-ready and only the CRF Annotation toolbar button is active.

You then open the CRF Annotation tool and select a series of settings that control both the type of annotations to include in the PDF and how you want it displayed. Then you save the annotated form to your file system.

When the GLE sends a copy of the DCI layout to the PDF DEW there is no further connection to the GLE or to Oracle Clinical. The file that is displayed in the PDF DEW is standalone – you can copy, save, or delete it and there is no impact on the DCI layout in OC. If you subsequently update the DCI form in the GLE, those changes are not transferred to a previously generated annotated CRF that is open in the PDF DEW. In that case, you would simply create another annotated CRF.

Since the annotated CRF is separate from the DCI layout in the GLE, you can use the tools included with Adobe Acrobat to modify it as you see fit. It is a discrete PDF file, that you can save, add further comments to, make a copy of, or delete, all within the functionality of Acrobat. In addition, you can re-open the CRF Annotation Tool and change its settings as often as necessary, either to fine-tune the information in the annotations or to create multiple copies form with different annotation configurations.

An annotated CRF is generally defined as a blank CRF with markings, or annotations, that coordinate each datapoint in the form with its corresponding dataset name. Essentially, an annotated CRF communicates where the data collected for each Question is stored in the database.

In Oracle Clinical, the annotated CRF provides linkage between database objects and the DCI and DCM definitions, and DCM Questions and Question Groups, as these definitional objects are laid out in the associated DCI layout.

Requirements

You must have Adobe Acrobat 6.0.3 installed on your system in order to generate annotated CRFs. In addition, the current version of the OPA PDF plug-in must be installed. Note that the PDF DEW that you use to manage annotations is comprised of the Adobe Acrobat and OPA plug-ins running in an instance of Microsoft Internet Explorer. If you open an annotated CRF file in the Adobe Acrobat window, the RDC toolbar will not be displayed.

Annotation Placement Styles

There are two "styles" for placing the annotations on the form: In Place and Index . You use the Annotation Placement Setting setting to determine which to use. There are certain differences between the two that may affect which you select.

This section describes the following tasks:

Annotating a DCI Form

Working with an Annotated CRF in Adobe Acrobat

The annotated CRF that this process described here generates, provides all of the components that are required for an annotated CRF, suitable for inclusion in regulatory submissions. You initiate the process of creating an annotated CRF from the Graph Layout Editor (GLE).

The procedure described here is also applicable if you want to annotate a Form Layout Template (FLT) or a DCM layout.

To create an annotated DCI form:

Open the DCI form in the GLE and click the Create Annotated Layout command in the File menu. The system opens the Print Preview Annotated Layout window.

Select a report server and click the OK button. The system opens the PDF in an Internet Explorer instance, with the RDC Toolbar displayed.

Click Annotated CRF on the RDC toolbar. The system opens the CRF Annotation Tool window; see "Using the CRF Annotation Tool Window" .

In the CRF Annotation Tool window, select the options that will display the required annotations in the form.

Click the OK button. The system creates the annotations as PDF comments and displays them in the CRF.

Because the annotations are Adobe Acrobat comments, you can use any of the tools that are available in Acrobat to change how annotations are displayed, printed, or saved.

If you want to change how any of the annotations are constructed or displayed, open the CRF Annotation Tool, change settings, and click the OK button to re-display the annotations.

Use the Adobe Acrobat Save button to save the annotated CRF as PDF file.

When you generate an annotation from the Graphical Layout Editor, Oracle Clinical creates a standalone PDF file that you can manage as needed. This includes adding comments to the file that are in addition to the annotations. Essentially, you can use all of Adobe Acrobat's functionality to further modify the annotated CRF file.

Displaying Acrobat Toolbars

Because annotated CRFs are displayed in the PDF DEW, you do not have access to the Adobe Acrobat menus. Therefore, you should display several of the Acrobat toolbars so you can access certain features that assist in the review and maintenance of your annotation files. You may find these toolbars helpful:

To access any toolbar, right-click in the toolbar area and select an item in the drop-down list. You can also move the toolbars once they are displayed.

Saving an Annotated CRF

You save an annotated CRF in the same way that you save any other PDF file in Adobe Acrobat. You can save multiple copies of the annotated PDF.

To save a copy of the annotations, click the Save a Copy button, which is in the Acrobat File toolbar. The system displays the Save a Copy... window, which you use to select a directory and file name for the new file. The file is saved in PDF format.

Opening a Saved Annotated Form

When you create an annotated form, the system creates a PDF file that you can then save, copy, and modify further. When you save and close the annotated form and the PDF DEW closes, use this procedure to re-open it.

Open Microsoft Internet Explorer.

Choose Open... from the File menu.

In the Open window, use Browse to locate the saved annotated form and open it. The form will have a *.pdf extension.

When the form opens, you have access to the Acrobat tools and the PDF DEW Annotation. Use either to review or modify the annotated file.

When the form opens in the browser window, the Adobe Acrobat and the OPA plug-ins are activated. This gives you access to all of Acrobat's functionality, as well as that of the CRF Annotation Tool. In order to use the CRF Annotation Tool, the form must be opened within a Microsoft Internet Explorer window.

You can open an annotated PDF file in Adobe Acrobat, however the RDC toolbar, which is a component of the PDF DEW and includes the Annotated CRF button, is only available when you use Internet Explorer to open the file.

Methods of Organizing and Viewing Annotations

Because annotations are PDF comments, you can use the Adobe Acrobat Comments List feature to list, review, and modify them. You access the Comments List either by clicking the Comments tab in the lower left-hand corner of the PDF DEW or the Comments List command in the Review & Comment drop-down list.

When you generate an annotated layout, as described in "Procedures" , the GLE opens the form in version of the PDF data entry window (DEW) that provides the capability to annotate the form. In this context, only the Annotation Tool button is active in the DEW.

Figure 12-1 CRF Annotation Tool - Field Annotations tab

You access CRF Annotation Tool by clicking Annotate CRF on the RDC Toolbar in the DEW. This button is only active when you use the Create Annotation action in the GLE.

Figure 12-2 CRF Annotation Tool - DCM Block Annotations Tab

The CRF Annotation Tool window is comprised of two tabs: Field Annotations and DCI Block Annotations. As Figure 12-1 and Figure 12-2 illustrate, the set of configurations on each tab are similar. However, there are certain differences, which are based on the what each type of annotation entails.

Both tabs include a Display Characteristics section, which allows you to control certain formatting aspects and the location of the annotations. The Field Annotations tab includes a Header Field/Question Attributes section, which you use to configure annotations associated with the DCI and DCM header data fields. The DCM Block Annotations tab includes a DCM Block Attributes section. This section includes settings for include DCI and DCM names, and a subsection that consists of settings for DCM attributes. The section also displays settings from the Field Annotations tab in read-only mode.

DCM Attributes Section

The DCM Attributes section, which is present on each tab, controls DCM-specific annotations at the header/Question field or the DCM block level, depending on which tab you use. The graphic in Figure 12-3 depicts the section that is present in DCM Block Annotations tab. The section in the Field Annotations tab is identical, with the exception of the Show Default Data Extract View Name setting, which is only present in the DCM Block Annotations tab.

The settings that are the same on each tab are: DCM Name, DCM Short Name, DCM Layout and DCM Subset. The settings on each tab are independent of one another. The fundamental difference between the tabs is in determining which annotation is affected.

The DCM Attributes settings in the:

Field Annotation tab control whether the item is included in the annotations for each DCM field

DCM Block tab control whether the item is included in the annotation that is displayed at the top of each DCM block.

Figure 12-3 DCM Attributes Section – DCM Block Annotations Tab

The DCM Attributes section on the DCM Block Annotations tab also includes a Show Default Data Extract View Name setting, which, when selected, includes the name of the data extract view in a separate annotation that is displayed at the top of each DCM block. This setting is not present on the Field Annotations tab because data extract views are applicable at the DCM block level.

Components of the Field Annotations Tab

The Field Annotations tab, which is depicted in Figure 12-1, "CRF Annotation Tool - Field Annotations tab" , consists of two sections: the Header Field/Question Attributes section, which you use to configure annotations at the field level, and the Display Characteristics section, which you use to modify how these annotations are displayed. The settings in the Header Field/Question Attributes section are listed and described in Table 12-2 . Each listed setting is selected using a check box. The meta-data name that corresponds to each attribute is in parentheses after the corresponding annotation label.

Table 12-1 Header Field/Question Attributes Section

Components of the DCM Block Annotations Tab

The DCM Block Annotations tab, which is depicted in Figure 12-2, "CRF Annotation Tool - DCM Block Annotations Tab" , controls the annotations that are displayed at the start of each DCM block. It consists of two sections: the DCM Block Attributes section, which you use to configure annotations at the DCM Block level, and the Display Characteristics section, which you use to modify how these annotations are displayed. The components of the DCM Block Attributes section is further divided into theDCM Attributes Section, which is described above, and two other settings, which are listed and described in Table 12-2 . Each setting is selected using a check box. The meta-data name that corresponds to each attribute is in parentheses after the corresponding annotation label. Unless noted otherwise, each setting is present on both tabs.

Table 12-2 Components of the DCM Block Attributes Section

Components of the Display Characteristics Section

The Display Characteristics section is present on each tab. Its components are listed and described in Table 12-3, "Display Characteristics Section" . The settings in these sections are identical in both tabs, however you manage the display of annotations independently on each tab. This allows you set up the display of header-level annotations differently then field-level annotations.

Table 12-3 Display Characteristics Section

Display Meta-Data Labels Setting

This setting causes the meta-data name of each object to be included in the annotation key string. It is active on both tabs and controls both types of annotations: when you change this setting on one tab, it is also changed on the other.

When you change this setting, its effect is immediately displayed in the Annotation Key Field . The meta-data names are appended to each relevant setting in the window. Selecting this setting causes each annotation to include the meta-data identifier for each setting in the annotation string and to place the actual value in angle brackets, with a colon between the two items.

For example, if you select the following settings in the Field Annotations tab and do not select the Display Meta-Data Labels setting, the resulting dot notation in the Annotation Key field is displayed in the top graphic in Figure 12-4 :

DCI Name (DCI) – DEMOG

DCM Name (DCM) – DEM

DCM Short Name (DCM_Short) – PHYS

DCM Subset Name (DCM_Subset) – BP

The actual annotation that is displayed adjacent to each field is:

When you select the Display Meta-Data Labels setting, the resulting dot notation in Annotation Key field is displayed in the lower graphic in Figure 12-4 . The actual annotation that is displayed adjacent to each field is:

Figure 12-4 Example Usage of the "Display Meta-Data Labels" Setting

Show DCI Name at top of every page Setting

This setting displays the name of the DCI at the top of each page in the annotated form. It is active on both tabs and controls both types of annotations: when you change this setting on one tab, it is also changed on the other. This setting is useful for CRFs that are longer then one page, where you do not want to include DCI Name (DCI) setting with each field annotation.

Annotation Key Field

This field is not a setting, but it displays a generic string, in dot-notation format, that is based on the settings that are currently selected in the tab. As you change settings, the contents of the string change, showing you how much information will be included in each annotation, based on the choices you have made in the window. It also changes the generic string based on the Display Meta-Data Labels Setting .

Annotation Placement Setting

This setting determines how the annotations are displayed on the CRF page. The choices are Index and In Place . Index style uses numbered footnotes to link to the actual annotations, which you view using the Acrobat Comments tool. In Place style displays each annotation adjacent to the corresponding data field.

This setting is only active on the Field Annotations tab, however it controls how all annotations is placed in the form (see "Components of the Field Annotations Tab" ).

Text Setting

This setting allows you to specify the font color that is used for the annotations, using a standard color palette to choose. The font color can be different for Field and the DCM annotations, so you set this for each type of annotation. Using different text and background colors is useful for differentiating between the different types of annotations.

Figure 12-5 Color Palette for Text Setting

Background Setting

This setting allows you to specify the background color that is used for the annotations, using a standard color palette to choose. The color can be different for Field and the DCM Block annotations, so you set the background color for each type of annotation. The standard color palette is depicted in Figure 12-5 .

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Creating annotated CRFs is an important but almighty task. You need to manually create annotations for every single form. Then convert your forms into PDF. That’s a lot of time and resources. But you don’t need to do it the hard way…

Once your CRF designs are created in ryze, you can easily annotate them – all in the same place. We simply use your metadata to make the annotations for you. Then just press a button to see what your CRF design looks like in PDF format. Easily make any changes. And instantly preview again until you’re done. Imagine how much time you could save, and how much more productive you could be!  

And remember, if you’re building studies from your standards library, you can reuse annotations. That’s even more time saved – with no effort at all! See why you should switch to automated CRF annotations .

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How you’re better off with ryze, instant sdtm annotations.

ryze annotates your forms, leaving you to simply push a button for your PDF. Why wait!

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What are annotated CRFs?

An annotated CRF is a blank form that contains annotations (or notes) next to each form question. Annotations show the location of data, along with related dataset names, and variable names within those datasets in the submission.

In other words, annotations describe where the data collected for each question is stored in the corresponding dataset. They show the origin of variables, and link between the fields on the form and the variables in the dataset.

Annotated CRFs are one of the mandatory deliverables for submission to the FDA for SDTM . Your SDTM annotations let the reviewer check metadata definitions, by tracing data that has come from the CRF. They also help promote standardization of data submitted in the industry.

Why use ryze for SDTM annotations?

Making SDTM annotated CRFs can be laborious and incredibly time consuming. ryze makes it much easier to create annotated CRFs with minimal effort.

Gone are the days of manually creating annotated CRFs each time. Then having to verify that it matches the collected data. Once the data acquisition forms for your study have been defined upfront, you can add annotations in your SDTM.

Then it’s a simple push of a button to generate a regulatory compliant SDTM annotated CRF. It’s based on your original study design, so you know it’s right. That means no more rushing to manually create your annotated CRF when pulling together your submission!

When you have end-to-end standards, your data acquisition forms are aligned with your downstream datasets. When creating a study from your standards, everything comes along. Your forms, terminologies, edit checks, datasets, and the annotations that drive the annotated CRF.

In other words, once you’ve created your standard annotated CRFs, you can reuse them from study to study.

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How we make annotated CRFs less of a chore

One of the main benefits of using automated annotated CRFs in ryze is that you have detailed control over your form layouts. You decide on the font, display format, placement, color and type of annotations.

Have many types of annotation? You can design annotations for more than mapping between fields on a form to variables in a dataset. You can create annotation notes next to fields for SAS Programmers, Data Management and reviewers.

Even provide other useful information, such as indicating which fields are required or hidden. Simply tailor annotations to fit how you want to work!

This is an example of an annotated Rave CRF. And here’s an example of an annotated paper CRF .

Previewing annotations

Why painstakingly create manual annotations on PDF’s, one form at a time. Let ryze do it for you and save time and resources to focus elsewhere. Just switch on the plugin of your choice. Then set your annotation type, display format, and font. Next, set your SDTM annotations on each field. Now you’re now good to go! And you can easily preview what your annotations will look like, so you know they’re correct!

What about reusing annotations?

You can reuse your standards and studies – including annotations – so you don’t have to do them again! This helps you maintain consistency across studies, standards, and in your SDTM. It also reduces the margin for error.

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What is an annotated CRF?

It’s a blank form used for collecting clinical data. It has annotations for each data point on the form with a corresponding dataset name and variables within that dataset.

Here’s a couple of examples:

Download a paper annotated CRF example.

Download a Rave annotated CRF example.

What are the benefits of annotated CRFs?

Annotated CRFs map data that’s collected on a form to where it’s stored in the database. Creating your annotated CRFs and SDTM annotated CRFs in Formedix is quick and easy to do. Reusing your standardized forms means they’ll be of high quality and consistent across studies. They’re easy to edit and you can see what they look like as you work on them. And your bookmarks are updated automatically! Find out more about why you should switch to automating annotated CRFs .

Why are annotated CRFs so important?

Annotated CRFs in PDF format, named “blankcrf.pdf” is mandatory for regulatory submissions.

What are SDTM annotated CRFs?

This is simply an annotated CRF that adheres to CDISC SDTM rules that allow for consistency and efficiency. Each SDTM annotation maps to an SDTM dataset.

Can I reuse annotations?

Yes. You can reuse your standardized content in Formedix. That means your annotated CRFs can be reused. So you don’t need to do them again! This reduces the chance of errors, and your studies and standards will be consistent.

Can I do different kinds of annotations on CRFs?

Yes. You can create annotation notes for different viewers as well as annotations for mapping forms to variables in a dataset.

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Annotating CRFs (Case Report Forms) is an important but almighty task. You need to manually create annotations for every single form, then convert your forms into PDF, which is a lot of time and resources.

However, you do not need to do it the hard way. You can see how it is done in Formedix, in the diagram above.

Once your CRF designs are created in Formedix, you can easily annotate them. We simply use your metadata to make the annotations for you. Then, just press a button to see what your CRF design looks like in PDF format. Easily make any changes. And instantly preview again until you’re done. Imagine how much time you could save, and how much more productive you could be.

Why use Formedix for SDTM annotations?

Formedix makes it much easier to create annotated CRFs with minimal effort. Gone are the days of manually creating annotated CRFs, then having to verify that it matches the collected data. Once the data acquisition forms for your study have been defined upfront, you can add annotations in your SDTM.

Then, it is one push of a button to generate a regulatory compliant SDTM annotated CRF, based on your original study design, so you know it is right. That means no more rushing to manually create your annotated CRFs when pulling together your submission.

When you have end-to-end standards, your data acquisition forms are aligned with your downstream datasets. When creating a study from your standards, everything comes along – your forms, terminologies, edit checks, datasets, and the annotations that drive the annotated CRF.

How Formedix makes annotated CRFs less of a chore

One of the main benefits of using automated annotated CRFs in Formedix is that you have detailed control over your form layouts. You decide on the font, display format, placement, colour, and type of annotations.

Types of annotation?

You can use annotations for more than mapping between fields on a form to variables in a dataset. You can create annotation notes next to fields for SAS Programmers, Data Management, and reviewers.

You can even provide other useful information, such as indicating which fields are required or hidden. Tailor annotations to fit how you want to work.

Previewing annotations

Why painstakingly create manual annotations on PDF’s, one form at a time? Let Formedix do it for you and save time and resources. Just switch on the plugin of your choice. Then, set your annotation type, display format, and font. Next, set your SDTM annotations on each field. Now you are good to go. You can easily preview what your annotations will look like, so you know they are correct.

Reusing annotations

You can reuse your standards and studies, including annotations, so you don’t have to do them again. That gives you consistency across studies, standards, and in your SDTM. It also reduces the margin for error.

A Basic Guide To Annotated CRF SDTM

What Is A CRF?

What is a sdtm, why have a crf and sdtm annotated together, what does crf sdtm do.

• Collect relevant information on subjects enrolled in your study
• Create a database of subject trial-related data
• Ensure quality control during data analysis
• Analyze data faster and more easily
• Easily prepare final reports

How Can You Implement An Annotated CRF SDTM?

There are two best practices to follow when designing an annotated CRF SDTM:

What should you consider when annotating.

• The CDASH/SDTM version number
• The SDTM version number
• The CDISC term identifier (CTI)
• The CDISC submission value (SV)
• All domains and variables (including those specific to your study features).
• All controlled terminology (code lists) and classifications for each domain/variable

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Best Practices for Annotated CRFs

The SDTM annotated CRF (aCRF) is a cumbersome submission document to create. It's also highly important. It visually documents how data are mapped from the CRF to SDTM. Because this is mostly a manual task, it is key to know what makes a high-quality aCRF.

In this webinar, Amy Garrett reviews published guidance from regulatory agencies and provides best practices for CRF annotations. These practices ensure your aCRF meets current regulatory requirements and the needs of internal users.

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Answers to Your Questions

We received over 200 follow-up questions from you. That's a lot of questions! So we decided to group them into the categories below and answer them in our upcoming blog posts. As new posts are published, they will be linked below, so check back soon. 

• Annotation formatting
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• External data (diaries, ePRO, etc.)
• Specific examples - How is this annotated?
• Specific examples - Should this be annotated?

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• 14.4 Participant Data Entry
• 14.5 Participate and the Audit Log
• 14.6 Activate Participate
• 14.7 Design Participate Forms
• 15 OpenClinica Randomize
• 16.1 CDISC ODM XML
• 16.2 Clinicaldata (Import and Retrieve Clinical Data)
• 16.3 Participants (Add or Update a Participant)
• 16.4 Participants/Bulk (Add and Update Bulk List of Participants)
• 16.5 Retrieve Participant Contact Information
• 16.6 Events (Create and Update Single Study Event)
• 16.7 Bulk Create and Update Study Events
• 16.8 Bulk Actions Log
• 16.9 Participants (Get Participants at Study Level or Site Level)

17.1 Generating Annotated eCRFs

• 17.2 Suggested SOPs
• 18.1.1 Form Card
• 1.1.1 Verify Source Data
• 1.1.2.1 View by CRF or by Subject
• 1.1.2.2 Find and Organize SDV Data
• 1.1.3 View Source Data Verification Status
• 1.1.4 Reset Source Data Verification Status
• 1.2.1 Audit Logs Page for a Subject
• 1.2.2 What the Study Audit Log Tracks
• 1.3 Manage Groups
• 1.4.1 Find and Organize CRFs
• 1.4.2 View Original CRF and CRF Versions
• 1.5.1 CRF Version Migration Screencast
• 2.1.1 Define Dataset
• 2.1.2 Generate and Download Dataset
• 2.2.1 Access Dataset Definitions
• 2.2.2 Archive of Exported Dataset Files
• 2.3 Edit Dataset
• 2.4.1 Browser Settings for Downloading Files
• 2.4.2 Saving Downloaded Dataset Files
• 2.5.1.1 Header Table Format
• 2.5.1.2 Data Table Format
• 2.5.1.3 Variable naming convention
• 2.5.2 HTML Format
• 2.5.3 Excel Spreadsheet Format
• 2.5.4 SPSS Format
• 2.5.5 Data Mart Format
• 2.5.6 CDISC ODM Formats
• 2.5.7 SAS Data and Syntax
• 2.6.1 SPSS Conceptual Mapping
• 2.6.2 Creation of SPSS Data Definitions from OpenClinica CRF Item Properties
• 2.6.3 Use of [EVENT HANDLE] and [CRF HANDLE] Appended to Variable Names
• 2.6.4 Mapping between SPSS types and OpenClinica CRF ITEM Data Types
• 2.6.5 Handling of OpenClinica Null values
• 2.6.6.1 Syntax for VALUE LABELS
• 2.6.6.2 SPSS Data Definitions for Built-in System Fields
• 2.7 Data Mart (OpenClinica Enterprise Edition)
• 2.8 Importing OpenClinica Data Into R
• 2.9 Importing OpenClinica Data into STATA
• 3.1 View Study
• 3.2.1 Status of Study
• 3.3.1 About Study Details
• 3.4.1 About CRFs in OpenClinica
• 3.4.2.1 CRF Template - General Constraints
• 3.4.2.2 Scope of CRFs and Items
• 3.4.2.3 CRF Versioning
• 3.4.2.4 CRF Template Properties
• 3.4.2.5 CRF Template Elements
• 3.4.3.1 About CRF Versions
• 3.4.4 Designing CRFs
• 3.4.5 Create a CRF
• 3.4.6 Providing Content for a Defined CRF
• 3.4.7 Upload a Defined CRF
• 3.4.8 Table of CRFs
• 3.4.9 Edit the Defined CRF Name and Description
• 3.4.10.1 Replace a Defined CRF
• 3.4.10.2 Add a New Version of a Defined CRF
• 3.4.11 Remove, Restore, and Delete Defined CRFs
• 3.5.1 Create Event Definitions
• 3.5.2 View Event Definitions
• 3.5.3 Edit Event Definitions
• 3.5.4 Remove and Restore Event Definitions
• 3.6.1 About Subject Group Classes
• 3.6.2 Create Subject Group Class
• 3.6.3 Edit Subject Group Class
• 3.6.4 Remove or Restore Subject Group Class
• 3.7 Create Rules
• 3.8.1 About Sites
• 3.8.2 Create Site
• 3.8.3 View Site Information
• 3.8.4 Edit Site Information
• 3.8.5 Remove or Restore Site
• 3.9.1.1 About User Information in the Study Setup Module
• 3.9.2 Assign Users to Current Study or Site
• 3.9.3 Change User Role at Current Study or Site
• 3.9.4 Remove User from Current Study or Site
• 4.1 Definitions and Acronyms
• 4.2 OID Overview
• 4.3 Rules Applicability
• 4.4.1 Rule Assignment and Rule Definition
• 4.4.2 Expression Element
• 4.4.3 Target Element
• 4.4.4 Action Types
• 4.4.5 Testing Expressions
• 4.5.1 Manage Rules (Study Level)
• 4.5.2 Export Rules
• 4.5.3 Manage Rules (Item Level)
• 4.6.1 Accessing Rule Designer
• 4.6.2 Building Rules in Rule Designer
• 4.6.3 Testing Rules in Rule Designer
• 4.7.1 Equal or Not Equal To
• 4.7.2 Greater Than or Equal To
• 4.7.3 Less Than or Equal To
• 4.7.4 Arithmetic Operators
• 4.7.5 6.7.5 The Contains Operator
• 4.8.1 ShowAction Models
• 4.8.2 InsertAction Models
• 5.1.1 User Types
• 5.1.2 User Roles
• 5.2.1 Summary of Features Available to User Roles
• 5.2.2 Submit Data Module - Permissions
• 5.2.3 Monitor and Manage Data Module - Permissions
• 5.2.4 Extract Data Module - Permissions
• 5.2.5 Study Setup Module - Permissions
• 5.2.6 Administration Module - Permissions
• 5.2.7 Module for Other Features - Permissions
• 5.3 View, Assign, and Modify Users and Roles
• 5.4 User Matrix
• 5.5.1 LDAP/Active Directory Configuration
• 5.5.2 Adding a LDAP User to OpenClinica.
• 6.1.1.1 Re-Using Elements from One Study in Another Study
• 6.1.2 Remove or Restore a Study
• 6.2.1 Create a New User
• 6.2.2 About User Information in the Administration Module
• 6.2.3.1 View User Information
• 6.2.3.2 Edit User Information
• 6.2.3.3 Change User Role
• 6.2.3.4 Assign User to Study or Site and to Role
• 6.2.3.5 Remove or Restore User
• 6.2.4 Monitor User Access
• 6.2.5.1 Set Lockout Feature
• 6.2.5.2 Unlock a Locked-Out User
• 6.2.5.3 Additional Password Configuration Options
• 6.2.5.4 Configure Password Requirements
• 6.3.1 View Subjects in All Studies
• 6.3.2 View Subject Details
• 6.3.3 Edit Subject Details
• 6.3.4 Remove and Restore Subject in System
• 6.4 Administer CRFs
• 6.5.1.1 Create an Import Job
• 6.5.1.2 View Scheduled Import Jobs
• 6.5.1.3 Modify Scheduled Import Jobs
• 6.5.2.1 Create an Export Job
• 6.5.2.2 View Scheduled Export Jobs
• 6.5.2.3 Modify Scheduled Export Jobs
• 6.5.3 View or Cancel Data Exports
• 7.1 Printing a Blank CRF or Blank Casebook
• 7.2 Printing a Subject CRF or Subject Casebook
• 7.3 Printing Tips
• 8.1 Activate and Build OpenClinica Participate for your Study
• 8.2.1 OpenClinica Participate Forms
• 8.2.2 Best Practices
• 8.3 Connect Participants
• 8.4 What if a Participant Can't Connect?
• 8.5 Date Pickers
• 9 OpenClinica Randomize
• 10.1 System Requirements
• 10.2 Install OpenClinica
• 10.3 Install OpenClinica 3.4
• 10.4 Install OpenClinica 3.3 on Linux
• 10.5 Install OpenClinica 3.3 on Windows
• 10.6 Upgrade to OpenClinica 3.3 on Linux
• 10.7 Upgrade to OpenClinica 3.3 on Windows
• 10.8 Install OpenClinica 3.2 on Linux
• 10.9 Install OpenClinica 3.2 on Windows
• 10.10 Upgrade to OpenClinica 3.2 on Linux
• 10.11 Upgrade to OpenClinica 3.2 on Windows
• 10.12.1 Overview of Installation on Linux Systems
• 10.12.2 Operating System Requirements
• 10.12.3 Download Installation Files
• 10.12.4 Install Java
• 10.12.5 Install Tomcat
• 10.12.6 Install PostgreSQL Database
• 10.12.7 Set Up the PostgreSQL Database
• 10.12.8 Deploying OpenClinica within Tomcat
• 10.12.9 Deploying OpenClinica Web Services within Tomcat
• 10.12.10 Set Tomcat to Start
• 10.12.11 Configure OpenClinica for Optimum Performance
• 10.12.12 Configure the OpenClinica Application
• 10.12.13 Configure the OpenClinica Web Services
• 10.12.14 Description of datainfo.properties File
• 10.12.15 Description of datainfo.properties File for Web Services
• 10.12.16 Verify Access to OpenClinica
• 10.12.17 Verify Access to OpenClinica Web Services
• 10.12.18 Configure Tomcat to Use HTTPS
• 10.12.19 Verify the Installation
• 10.13.1 Overview of Installation on Windows Systems
• 10.13.2 Software Dependencies and Operating System Requirements
• 10.13.3 Install Java
• 10.13.4 Install PostgreSQL Database
• 10.13.5 Install Tomcat
• 10.13.6 Install OpenClinica Package
• 10.13.7 Install OpenClinica Web Services Package
• 10.13.8 Set Up the PostgreSQL Database
• 10.13.9 Configure Tomcat
• 10.13.10 Configure OpenClinica for better Performance
• 10.13.11 Configure the OpenClinica Application
• 10.13.12 Configure the OpenClinica Web Services
• 10.13.13 Start Tomcat
• 10.13.14 Verify the Installation
• 10.13.15 Verify the Installation of OpenClinica Web Services
• 10.14.1 Overview of the Upgrade Process on Linux Systems
• 10.14.2 Overview of the Upgrade Process for Web Services on Linux Systems
• 10.14.3 Back Up OpenClinica
• 10.14.4 Upgrade OpenClinica
• 10.14.5 Upgrade OpenClinica Web Services
• 10.14.6 Manual Database Updates
• 10.14.7 Verify the Upgrade
• 10.14.8 Verify the Upgrade for OpenClinica Web Services
• 10.15.1 Overview of the Upgrade Process on Windows Systems
• 10.15.2 Software Dependencies and System Requirements
• 10.15.3 Back Up OpenClinica
• 10.15.4 Manual Database Updates
• 10.15.5 Verify the Upgrade
• 10.15.6 Upgrade OpenClinica
• 10.15.7 Back Up OpenClinica Web Services
• 10.15.8 Verify the Upgrade for OpenClinica Web Services
• 10.15.9 Upgrade OpenClinica Web Services
• 10.16.1 Installing and Using VirtualBox
• 10.17.1 Set Up Oracle for OpenClinica Versions Pre-3.1.2
• 10.17.2 Set Up Oracle for OpenClinica 3.1.2 or Above
• 10.18 Operating System Installation
• 11 Glossary
• 12.1.1 Creating a CRF
• 12.1.2 The Calculation Script
• 12.1.3 Adding A Fancy Button
• 12.1.4 Example Files
• 12.2.1.1 Additional Tips
• 12.2.1.2 Example Files
• 12.3 Using the Decode() Function
• 12.4.1 Introduction to Partial Dates in OpenClinica
• 12.4.2 Extracting Partial Dates in Data Mart
• 12.5 HTML Tips to Enhance Your eCRF
• 13 OpenClinica Community Tools and Tips
• 14 OpenClinica Conference Presentations
• 15.1.1 Add New Subject from Subject Matrix
• 15.1.2 Add Subject from Tasks Menu
• 15.1.3 Assign or Reassign Subject to Site
• 15.1.4 Adding a Subject to More than One Study
• 15.2 Schedule an Event
• 15.3.1.1 About the Events Table
• 15.3.2 Update Events
• 15.3.3 About the Event Status
• 15.3.4.1 Sign an Event
• 15.3.4.2 Sign a Casebook (Entire Subject Record)
• 15.4.1 Enter Data Into a CRF
• 15.4.2 CRF Unavailable
• 15.4.3 Double Data Entry
• 15.4.4 CRF Status
• 15.4.5 Editing and Adding Data to Previously Saved CRF Sections
• 15.5.1 Import the Data File
• 15.5.2 Data File for Import
• 15.5.3.1 View Study Details to Determine OIDs
• 15.5.3.2 View the Study Metadata File to Determine OIDs
• 15.5.4 Create the Data Import File
• 15.5.5 Validate and Check the Data Import File
• 15.5.6 Example Data Import File
• 15.6.1 About Discrepancy Notes
• 15.6.2 Types of Discrepancy Notes
• 15.6.3 Status of a Discrepancy Note
• 15.6.4.1 Create a Discrepancy Note
• 15.6.4.2 View a Discrepancy Note
• 15.6.4.3 Update a Discrepancy Note
• 15.6.5.1 Notes and Discrepancies Table
• 15.6.5.2 Actions to Take for Discrepancy Notes
• 15.6.5.3 Organize and Find Discrepancy Notes
• 15.6.5.4 Download Discrepancy Notes
• 15.7.1 Remove and Restore Study Event CRFs for a Subject
• 15.7.2 Delete Study Event CRFs for a Subject
• 15.7.3 Remove and Restore Study Events for a Subject
• 15.7.4 Delete Study Events
• 15.8.1 Overview of Subject Matrix
• 15.8.2 View and Enter Event Data in Subject Matrix
• 15.8.3 Show More Information About Subjects in Subject Matrix
• 15.8.4 Find and Organize Data in Subject Matrix
• 15.8.5 Actions for a Subject in Subject Matrix
• 15.8.6 View Event Details in Subject Matrix
• 15.8.7 View and Edit Details for a Subject in Subject Matrix
• 16.1.1 Log In to OpenClinica
• 16.1.2 Get a New Password
• 16.1.3 Change Current Study or Site
• 16.1.4 Update User Profile
• 16.1.5 Log Out of OpenClinica
• 16.1.6 Get Support
• 16.2.1 Top of Page
• 16.2.2 Navigation Bar
• 16.2.3.1 Status Icons
• 16.2.3.2 Action Icons
• 16.2.3.3 Complete Icon List
• 16.2.4 Body of Home Page
• 16.2.5 Bottom of Page
• 16.3.1 Data Manager and Study Director Home Page
• 16.3.2 Investigator Home Page
• 16.3.3 Monitor Home Page
• 16.3.4 Data Entry User Home Page
• 16.3.5 Data Specialist Home Page
• 16.3.6 Clinical Research Coordinator Home Page
• 16.4 Citing OpenClinica
• 1.1 OAuth and OpenClinica
• 1.2 RESTful URLs
• 1.3 RestFul URL access to OpenClinica metadata and print Resources.
• 1.4.1 Calling Methods and Arguments
• 1.4.2 Responses
• 1.5.1 Calling Methods and Arguments
• 1.5.2 Responses
• 1.6.1 Calling Methods and Arguments
• 1.6.2 Responses
• 1.7.1 Calling Methods and Arguments
• 1.7.2 Responses
• 2.1 Using OpenClinica Web Services
• 2.2.1 create (Creates a new studySubject)
• 2.2.2 listAllByStudy (List studySubjects in a study)
• 2.2.3 isStudySubject (Queries OpenClinica if studySubject exists in a Study)
• 2.3.1 schedule (Schedules an event)
• 2.4.1 Import
• 2.5.1 getMetadata (Returns study metadata)
• 2.5.2 listAll (Lists studies)
• 2.6.1 listAll (Lists study event definitions in study)
• 2.7 Screencasts: Intro, Installation, and Usage Examples
• 3 CRF Template Elements
• 4 Database Schema
• 5.1 Overview with Definitions and Acronyms
• 5.2.1 DATE Datatype
• 5.2.2 PDATE Datatype (Complete Dates)
• 5.2.3 PDATE Datatype (Month and Year Provided)
• 5.2.4 PDATE Datatype (Year Provided)
• 6.1 Item Properties
• 6.2 Canonical Datatypes
• 7.1 Configure OpenClinica for Internationalization
• 7.2 Install Desired Translations
• 7.3 Translate OpenClinica into New Languages or Maintain Existing Translations
• 7.4 Recommended steps to translate strings
• 7.5 OpenClinica Data Extract File Format
• 8.1 Configure Postgres to Allow Additional Connections
• 8.2 Email Configuration and Troubleshooting Tips
• 8.3.1 Community Contributed Backup Scripts
• 8.4 Loading the Demo Database
• 9 Build a Data Extract or Reporting plug-in
• 10.1.1 Syntatic Constraints
• 10.1.2 System Conformity
• 10.1.3 Vendor Extensions
• 10.2 Limitations on Support for Generated and Received ODM Files
• 10.3 Entities and Elements
• 10.4.1 Generation of OIDs
• 10.4.2 OID Scope, Context and Uniqueness Constraints
• 10.4.3 Clinical Data Keys
• 10.5 File Properties, Transactions and Element Ordering
• 10.6 Study Metadata Versions and Sites
• 10.7 Data Representations in ODM XML (Extract)
• 10.8 Data Representations in ODM XML (Import)
• 10.9 Item Data Types
• 10.10 Mapping of OpenClinica Elements to ODM
• 10.11 CDISC ODM XML Schema
• 10.12 Global Case Report Form in ODM repesentation
• 11.1 Using the OpenRosa API in OpenClinica (experimental)
• 1 OpenClinica 4 – Release Notes 2023
• 2 OpenClinica 4 - Release Notes 2022
• 3 OpenClinica 4 - Release Notes 2021
• 4 OpenClinica 4 - Release Notes 2020
• 5 OpenClinica 4 - Release Notes 2019
• 6 Release Notes - OpenClinica Insight - 2019
• 7 OpenClinica 4 - Release Notes 2018
• 8 Release Notes - OpenClinica Insight - 2018
• 9 OpenClinica 4 - Release Notes 2017
• 1 Release Notes - OpenClinica 3.16 - (Current Production Release - 03-Nov-2020)
• 2 Release Notes - OpenClinica 3.15
• 3 Release Notes - OpenClinica 3.14
• 4 Release Notes - OpenClinica 3.13
• 5 Release Notes - OpenClinica 3.12
• 6 Release Notes - OpenClinica 3.11
• 7 Release Notes - OpenClinica 3.10
• 8 Release Notes - OpenClinica 3.9
• 9 Release Notes - OpenClinica 3.8
• 10 Release Notes - OpenClinica 3.7
• 11 Release Notes - OpenClinica 3.6
• 12 Release Notes - OpenClinica 3.5
• 13 Release Notes - OpenClinica 3.4.1
• 14 Release Notes - OpenClinica 3.4
• 15 Release Notes - OpenClinica 3.3
• 16 Release Notes - OpenClinica 3.2
• 17 Release Notes - OpenClinica 3.1.4.1
• 18 Release Notes - OpenClinica 3.1.4
• 19 Release Notes - OpenClinica 3.1.3.1
• 20 Release Notes - OpenClinica 3.1.3
• 21 Release Notes - Older Releases
• 1 Accessing Data Mart on OpenClinica Optimized Hosting
• 2 Accessing the Data Mart Local Deployment
• 3 How We Set Up Your Data Mart
• 4 Setting Up a PostgreSQL Server for Data Mart
• 5.1 System Architecture for Data Mart
• 5.2 Loading Data into the Data Mart
• 5.3 Data Mart Schema for Study
• 5.4 Data Types
• 5.5 SQL Joins for Related Tables
• 5.6 Reporting Status of CRFs and Events

This article describes a method for downloading annotated CRFs (a CRFs) which are automatically available for Data Manager roles within Study Runner. Annotated CRFs can be downloaded individually or an Annotated Casebook can be downloaded containing all CRFs for the entire study. 

Download Individual Annotated CRFs

• The Manage Case Report Forms (CRFs) page opens. Click the Download icon to download an individual Annotated CRF for the form version on that row. 

The downloaded PDF document will include a cover page with Study Name, Study OID, Form Name, Form OID, Form Version, and Form Version Initial Publish. It also includes the generated date and time in the footer.

While there are labels for the Event Name/OID and SDV Configuration for individual CRFs, the values are not displayed because the form could be in more than one event. Download the Annotated Casebook for the study to view these values. From the Manage Case Report Forms (CRFs) page, you can use the Annotated Casebook link to get all Annotated CRFs for the study, or follow the steps in the next section. 

Download the Annotated Casebook for the Study

The Annotated Casebook compiles the default versions of active forms in the study, collates them by event, and creates a PDF you can download. Each item includes annotations that describe the form’s configuration. This option is only available to Study Data Manager roles and is only available when accessing the study at the Study level (the option is not available when logged in at the Site level).

• From the Tasks menu in Study Runner, select Annotated Casebook.

Note: The Annotated Casebook page can also be accessed by clicking the Annotated Casebook link on the Manage Case Report Forms (CRFs) page.

• Select the Include archived events and forms checkbox if you want to include these in the PDF, otherwise only Active forms will be included by default. Click Get PDF .

• A green message bar will appear letting you know that the PDF is being generated. This may take some time if it is a large study. Click the Bulk Actions Log link to navigate to the Bulk Actions Log and view the status of the job.

• Click the Download icon to download the Annotated Casebook PDF that was generated.

The Annotated Casebook includes the date and time it was generated and the page number on each page. It also includes:

• A cover page with the name of the study, the date and time it was generated, and the page numbers.
• A Table of Contents that includes the name of the study and the study OID, a heading for each event and a page number for each CRF below the associated event.
• A title sheet for each aCRF which includes Study Name, Study OID, Event Name, Event OID, Form Name, Form OID, Form Version, Form Version Initial Publish and SDV Configuration.
• An annotated CRF for each CRF included in the download.

Reviewing Annotated CRFs

When reviewing Annotated CRFs, text will appear in different colors to help differentiate the annotations. Each annotation is based off the form definition with similar names. Below is a list of the Annotation Labels, their associated names on the Form Definition, the color and the order which they will appear.

The Annotated values occasionally need to have some symbols changed from their value on the Form Definition to their value on the Annotated CRF. Below is a list of the original values from the Form Definition to the replacement value that will appear on the Annotated CRF along with each Annotated Label which may have that symbol change.

Note: Any label formatting done in the form definition will carry over to the annotated CRF. For example, if the label includes *label* then the label will be  bolded.

Annotated CRFs and Casebooks can be displayed in different languages (only for studies configured to support this). When a form has multiple languages configured, the annotated CRF or Casebook will display in the same language that would appear for the user when loading opening a form to edit on screen.

This only applies to the labels and hints defined for the form. Annotations are always in English as described above.

Note:  OpenClinica does not yet have every language configured and tested. New languages are added to the system by request. If your preferred language is not currently set up in OpenClinica, please reach out to our Support team to discuss getting it added.

Revision History