Data Entry in InForm 4.6 Course version 1.0 [27 February 2013]

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Junior Sparks
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1 This course will show you how to enter data in InForm version 4.6 The course is suitable for CTC or external staff in the following roles: Clinical Trials Assistant Data Manager Site Data Manager/Study Nurse Trial Coordinator Project Manager Other staff who want some basic awareness of InForm user interface e.g. Biostatisticians, Clinicians, Investigator / Co-Investigator Prerequisites Basic knowledge of Clinical Trials and Randomisation processes. Competence in using web based software applications. Completion of course: Introduction to InForm for CTC studies NHMRC Clinical Trials Centre,

2 This course is divided into sections as listed above NHMRC Clinical Trials Centre,

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4 Most date items require the full date, i.e. day, month and year. However some date fields may also include UNK in the dropdown list for day or month, so that partial dates can be entered, e.g. UNK/Mar/1982 When entering data for a Number item, if the data does not match the required format, a pop up box will appear when you click away from the item, specifying the requirement, e.g. The value must contain 2 decimal places. NHMRC Clinical Trials Centre,

5 There are two types of indented items used in InForm: Conditional Items and Compound Items. In a Conditional Item, there is a parent item and an indented child item. E.g. the parent item is Does the patient smoke?, the child item is If yes, specify frequency Data entry in the child item is only required depending on the parent item value. E.g. If yes, specify frequency is only required to be completed if the answer is Yes Conditional item data entry is guided: If you select Yes, the cursor will automatically move to the child item. If you select No, the cursor will move to the next parent question. NB: if data is entered in the child item, the parent item will automatically change to the corresponding parent item value double check these items carefully before submitting. E.g. if you select No for Does the patient smoke?, but then select a frequency of More than once a week, Does the patient smoke? will automatically change to Yes. NHMRC Clinical Trials Centre,

6 Compound items are subtly different to the conditional items shown earlier. Compound items are the same as conditional items as follows: There is a parent item and an indented child item. E.g. the parent item is Ongoing, the child item is If no, last dose date If no, last dose date is only required to be completed if the answer is No Compounds items are different from conditional items as follows: The cursor will not automatically indicate which data is required The parent item will not change to accommodate the child item value Compound item data entry is only guided by queries after ecrf submission CTC typically uses compound items where there are two or more child items dependent on a parent item, and when a child item is applicable for more than one parent item response. If data is entered for any one of the child items, the compound item is not highlighted in yellow, i.e. the data is not marked as missing although the item is incomplete. This is managed by queries that trigger after the data is submitted. But please double check these items carefully before submitting e.g. check that all relevant sections are completed, and the responses are not contradictory. NHMRC Clinical Trials Centre,

7 Some items are Read Only, i.e. data cannot be entered or edited. Read Only items are usually populated when data is submitted, either by being calculated or copied from other parts of the database. Some items are Hidden, so it might appear that the ecrf does not contain any items ecrfs containing hidden items will be marked as CTC Use Only, and can be ignored. NHMRC Clinical Trials Centre,

8 Data Entry in InForm 4.6 Course version 1.0 [27 February 2013] NHMRC Clinical Trials Centre,

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10 If you miss the Form Submitted Successfully message, you can still tell that the data has been submitted, because the eraser is no longer visible ibl and instead the audit trail icon is visible. ibl NHMRC Clinical Trials Centre,

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12 A repeating section allows the user to create multiple instances of the same section of an ecrf, i.e. multiple rows. Repeating sections contain an Add Entry button. Tip: If an ecrf contains items on a regular form, as well as a repeating section, submit data in the regular form before clicking Add Entry NHMRC Clinical Trials Centre,

13 An entire row can be deleted by clicking on the # for the relevant row, then enter a reason for change, and click Delete. Deleted rows are displayed with a line through the data. Tip: A deleted row can be undeleted using the Undelete button (visible only for a deleted row). NHMRC Clinical Trials Centre,

14 A repeating ecrf allows the user to create multiple instances of the same ecrf. Repeating ecrfs contain a New button at the Top Right of the ecrf. After clicking New, the ecrf opens and data can be entered like a regular ecrf. When data is submitted, the repeat number is displayed. Another instance can be added by clicking New again. NHMRC Clinical Trials Centre,

15 There are two different ways you can view data entered on repeating ecrfs; the CRF View and the Summary View. To navigate to a specific repeat, select the relevant repeat number. This will take you to the CRF view for that repeat. In the CRF View, only data for the selected repeat is visible. NHMRC Clinical Trials Centre,

16 From the ecrf view, select [Summary] from the dropdown list to see the Summary View. In the Summary View, data for all repeats is visible. To navigate to a desired repeat from the Summary View, there are 3 options: -Select the relevant number in the dropdown list -Click the relevant number in the relevant row (in the # column) -Click the traffic light in the relevant row NHMRC Clinical Trials Centre,

17 An entire repeating ecrf can be deleted (e.g. if it was entered in error) by selecting Delete from the [Select Action] menu, then clicking Apply. Select the relevant row, then enter a reason for change, and click Delete. Deleted repeating ecrfs are displayed with a line through the data. Tip: A deleted repeating ecrf can be undeleted using the Undelete button (visible only for a deleted repeating ecrf). NHMRC Clinical Trials Centre,

18 A visit is a set of ecrfs. A repeating visit allows the user to create multiple instances of a visit, i.e. a set of ecrfs for each occurrence. Repeating visits contain a New button at the Bottom Left of the ecrf The Visit Selector shows the Date of Visit, i.e. the date entered at the start of the visit. Once the visit is created (by entering the Date of Visit), all of the ecrfs in the visit appear and data can be entered as required. When entering data in a repeating visit, always check the date in Visit Selector before entering data to ensure you are entering data in the correct visit. NHMRC Clinical Trials Centre,

19 Regardless of the order in which data is entered, visits will always appear in chronological order (from newest to oldest) according to the date of visit it entered (the date entered at the start t of the visit) it) NHMRC Clinical Trials Centre,

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22 A dynamic visit appears in response to a trigger. The trigger may be data entry in a trigger item or certain conditions being met. NHMRC Clinical Trials Centre,

23 A dynamic ecrf appears in response to a trigger. The trigger may be data entry in a trigger item or certain conditions being met. If a dynamic ecrf is triggered in error, revising the trigger item to the correct value will un-trigger the dynamic ecrf, i.e. it will disappear, unless data has been entered in the dynamic ecrf. Once data has been entered in a dynamic ecrf, revising the trigger item will have no effect the dynamic ecrf will remain. NHMRC Clinical Trials Centre,

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25 Missing data on started ecrfs can be identified by: In the Patient Case Book List: a yellow traffic light indicates missing data. In the Time and Events Schedule: a yellow traffic light indicates missing data. On an ecrf tab name: an apostrophe indicates missing data and/or queries. On an ecrf: data items highlighted in yellow indicate missing data. To enter missing data, simply enter the data and click submit. NHMRC Clinical Trials Centre,

26 Missing data items on unstarted ecrfs are not marked as missing on the ecrf. Missing data on unstarted ecrfs can be identified by: In the Patient Case Book List: a yellow traffic light indicates missing data. In the Time and Events Schedule: no lights indicates the ecrf has not been started. To enter missing data on an unstarted ecrf, simply enter the data and click submit. NHMRC Clinical Trials Centre,

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28 Once data has been submitted, any changes made to the data must be accompanied by a Reason for Change. The common reasons for change can be selected from a pre-defined list, however Other can be selected and a Reason for Change typed into the space provided. For the purposes of this training, Transcription Error is always selected, but in the live study database, select or enter the most appropriate reason. NHMRC Clinical Trials Centre,

29 To access the audit trail for an icon, click the audit trail icon next to any item that has had data submitted NHMRC Clinical Trials Centre,

30 If you want to delete an item, i.e. reset the item to blank, instead of typing a value, click the eraser in the Data Value(s) screen All deletions are logged in the Audit Trail NHMRC Clinical Trials Centre,

31 If an ecrf is entered in error, e.g. for the wrong patient, all data on the ecrf can be cleared in a single step (rather than deleting each hitem separately). An entire ecrf can be cleared by selecting Clear ecrf from the [Select Action] menu, then clicking Apply. Enter a reason for change, and click Clear. Tip: A cleared ecrf CANNOT be uncleared this process can only be reversed by re-entering data for each item. NHMRC Clinical Trials Centre,

32 Data Entry in InForm 4.6 Course version 1.0 [27 February 2013] NHMRC Clinical Trials Centre,

33 Where a data value cannot be entered because it is Not Done, Not Applicable or Unknown, enter a pre-defined comment. Tip: Before trying to enter a comment, submit any other data entered on the form first by clicking Submit. Tip: To enter a pre-defined comment for an item that already contains a value, use the eraser on the Data Value(s) tab to delete the data value first. NHMRC Clinical Trials Centre,

34 It is also possible to enter a comment at CRF level. An ecrf level comment is a comment that applies to the entire ecrf, not just one item. A pre-defined comment entered at ecrf level will appear for all items on that ecrf that do not already contain a value. NHMRC Clinical Trials Centre,

35 A text comment should not be the data value, but could be an explanation of the value e.g. blood pressure high because patient tjust ran up the stairs. A text comment should not be a query response. Text comments can also be entered at ecrf level, in the same way as pre-defined comments. Note: If a data value has already been entered for the item, the pre-defined comments of Not Done, Not Applicable and Unknown are not displayed in the Comment screen. NHMRC Clinical Trials Centre,

36 If a pre-defined comment has been entered, but the data value subsequently becomes available, delete the comment so that t the data value can be entered. NHMRC Clinical Trials Centre,

37 Data Entry in InForm 4.6 Course version 1.0 [27 February 2013] NHMRC Clinical Trials Centre,

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39 Manual queries are created by the CTC. Once a manual query has been answered by the site, the answer/new value must be reviewed by CTC. If the answer/new value is satisfactory, CTC closes the query. If the answer/new value is not satisfactory, CTC re-issues the query, e.g. requesting further clarification. NHMRC Clinical Trials Centre,

40 Auto queries fire automatically. Once an auto query has been answered by the site, the answer/new value is automatically reviewed by InForm. If the new value meets the programmed criteria, the query auto closes. If the answer/new value does not meet the programmed criteria, the answer/new value must be reviewed by CTC. If the answer/new value is satisfactory, CTC closes the query. If the answer/new value is not satisfactory, CTC re-issues the query, e.g. requesting further clarification. NHMRC Clinical Trials Centre,

41 There are two ways to navigate to a query. Via the ecrf or Via the Query Listing Queries can be identified by: In the Patient Case Book List: a red traffic light indicates open queries. In the Time and Events Schedule: a red traffic light indicates open queries. On an ecrf tab name: an exclamation mark indicates missing data and/or queries. On an ecrf: data items with query text highlighted in pink indicate an open query. NHMRC Clinical Trials Centre,

42 The Queries button gives access to the Queries screen, where queries can be viewed, filtered and managed. The Issuer is listed as autoquery for all Auto Queries. For all Manual Queries, the Issuer is the username of the person that created the query. The possible status for a Query are: Opened: The query requires a response from the site Answered: A site user has answered the query and the response is awaiting review Closed: The sites response has been reviewed and the answer is satisfactory Candidate: A draft query, not visible to sites Deleted: A candidate query that has been deleted NHMRC Clinical Trials Centre,

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44 When you answer an autoquery by changing a data value, InForm will check the new value you have entered. If it still fails the test (e.g. the value is still out of range), your new value is saved but a new query will be generated. If the new value satisfies the test, the query will be automatically closed. All manual queries will be reviewed by CTC. NHMRC Clinical Trials Centre,

45 When you respond to a Query by selecting or entering a reason, your response will be reviewed by staff at the Coordinating Centre. Tip: Although Changed data per query is one of the pre-defined answer reasons, when a data value is changed the query is automatically changed from opened to answered - it is not necessary to enter this reason manually simply click on the Data Value(s) tab to change the data value. NHMRC Clinical Trials Centre,

46 Data Entry in InForm 4.6 Course version 1.0 [27 February 2013] NHMRC Clinical Trials Centre,

47 Electronic signatures can only be performed by accredited Site Investigators and Co-Investigators. The Sign button will not be visible ibl to other users. Using the Sign buttons and completing the Electronic Signature Affidavit is equivalent to physically signing a paper CRF. It carries the same legal authority and implications as a physical signature on paper. Some ecrfs (e.g. SAEs) need signing during the study. This is study-specific refer to the Study Manual for details. The ecrb is required to be signed for EVERY subject ONCE at the end of the study. For both ecrfs and ecrbs, check that all data is final before signing - any further data entry or editing will invalidate the signature, and require re-signing. ecrfs and ecrbs requiring signatures can easily be located by using the Signatures screen: Click the Signatures button in the navigation bar Then filter by choosing the site, patient, type (CRF or Book) and status (Signed, Unsigned, All) at the top of the page. Investigators can access ecrfs and ecrbs for signing by clicking Sign or Sign Book in the Signatures screen. Other users can see the status of the form (signed or unsigned) but do not have access to Sign or Sign Book. NB: ecrfs and ecrfs will appear in the Signatures list as soon as data is entered. However, please check with the CTC that the ecrf or ecrb is finalised before performing any signatures. NHMRC Clinical Trials Centre,

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InForm Training Exercises For Data Managers

InForm 4.6 for CTC Studies TM InForm Training Exercises For Data Managers Version 1.0 15 May 2013 Copyright NHMRC Clinical Trials Centre Page 1 of 42 List of Exercises InForm Training Exercises for Data