ImageKids Study May 2013

 Contact Info………(3)  Basic Info…………(4)  Log In……………..(7)  Enrolment………...(10)  Clinical Data Entry.(34)  Blood Work……….(47)  Medications……....(53)  Surgical Procedures……….(62)  Baseline GI Asssessment………..(66)  PCDAI ……………….(70)  Specimen Collection..(75)  Disease Location Assessment …………(80)  Endoscopy Scoring....(85)  Baseline Radiological Assessment………….(91)  End of Study…………(92)

If you have any questions regarding this tutorial, please contact: * The next few slides outline which paper forms and electronic forms need to be filled in for each visit. * The electronic forms (eCRF) that correspond to each paper form are indicated Study Manager Gili Focht; Europe, Australia and Israel Shaare Zedeik Medical Center Jerusalem Tel: or Wendy Doda; North America The Hospital for Sick Children Toronto Tel: North American Study Coordinator Meagan Perry The Hospital for Sick Children Toronto Tel:

Paper FormElectronic Form (eCRF) Form 1: Visit 1 (Enrollment)Enrollment (pg 1 of 1) Form 2: Visit 1 (Clinical) Select “baseline” as the type of visit for all of the following forms:  Clinical (pg 1)  Bloodwork (pg 1)  Baseline Medications (pg 2)  Surgical Procedures (pg 3-4)  Gastroenterologist Global Assessment (pg 5-7)  PCDAI (pg 8-9)  Specimen collection (pg 10) Disease Location Assessment Endoscopic Scores Radiologist Global Assessment Disease Location Assessment (pg 1 of 1) Endoscopic Scores (pg 1 of 1) Radiologist Global Assessment (pg 1 of 18)

Paper FormElectronic Form Form 3: Follow-up Visits (Clinical) Select “follow-up” as the type of visit for all of the following forms:  Clinical (pg 1)  Bloodwork (pg 1)  Medications (pg 2)  Surgical Procedures (pg 3-4)  Gastroenterologist Global Assessment (pg 5-8)  PCDAI (pg 9-10) Disease Location Assessment Endoscopic Scores (only if endo done) Radiologist Global Assessment (only if MRE/P-MRI done) Disease Location Assessment (pg 1 of 1) Endoscopic Scores (pg 1 of 1) Radiologist Global Assessment (pg 1 of 1) **THE FOLLOWING FORMS SHOULD ONLY BE FILLED IN IF AN ENDOSCOPY AND/OR MRE IS PERFORMED BETWEEN THE ENROLLMENT AND 18 MO VISIT**

Paper FormElectronic Form Form 3: Follow-up Visits (Clinical) Select “follow-up” as the type of visit for all of the following forms:  Clinical (pg 1)  Bloodwork (pg 1)  Medications (pg 2)  Surgical Procedures (pg 3-4)  Gastroenterologist Global Assessment (pg 5-8)  PCDAI (pg 9-10)  Specimen collection (pg 11) Disease Location Assessment Endoscopic Scores Radiologist Global Assessment Disease Location Assessment (pg 1 of 1) Endoscopic Scores (pg 1 of 1) Radiologist Global Assessment (pg 1-18) Form 4: Study EndStudy End (pg 1 of 1)

Go to Imagekids.org, and select “Input Data” to be directed to the REDCap login page

 Use the login information provided to you by the study manager

 Use the “TAB” button to move between fields, if you use “ENTER” it will close the form without saving.  Always save the form you are working on before moving on to another form or subject.  In most cases you will need to answer a few preliminary questions to be able to enter data into the full eCRF form.  For example: to enter the bloodwork data, you will need to select “yes” to the question “Was bloodwork performed?” A dropdown form will appear for you to enter the information

Baseline

 You will begin entering your participant data by selecting “Add/Edit Records” which is found on the left on the Project screen

 Under “Form Status”, select “Complete”, “Unverified”, or “Incomplete”.  Only select “Complete” once all fields have been filled in  Select “Unverified” when you have started to enter the CRF but have not completed the entry.  “Incomplete” is the default and should indicate that you haven’t started to enter information yet.  Always keep the “incomplete/unverified/complete” status up to date Remember: Save your data or it will be lost!

 To add a new participant, enter the unique Study ID. Press enter and it will bring you to the navigation page.

 This is the main navigation page  Your progress is identified by the coloured buttons (shown in legend)  You choose the buttons to either create or update cases.  To start, select the red button beside “Enrollment”

* For all new subjects, the eligibility and consent section must be filled out prior to collecting any other information

 Your site ID is located in the drop down menu  You must meet the criteria for items 1 – 3 to continue.  Criteria 4 is required for the first arm of the study only

 A ‘reset’ is available on the right hand site of each form if you need to correct or re-enter the data for the form. Just click on it.

 If you indicate “YES” for any of the exclusion criteria, you cannot enter the participant on the study.

 Select which Arm you are enrolling the subject on. In the beginning of the study most subjects will go onto the first arm unless there is a reason that they cannot be followed for 18 months.

 Enter the date of consent. If you do not have the participant consent at the time of enrolment, you will not be able to continue filling out the eCRF.  Once “Yes” is selected, you will be able to enter the remaining demographic, ethnic heritage, and family history data. NOTE: Inclusion/exclusion information, as well as documentation of consent MUST be entered into the Enrollment eCRF form before you will be able to enter any information into the other eCRF forms!!!

 Calculated Age of Diagnosis will be calculated when the form loads (in red).  Estimated age will appear after age in years and months fields have been completed (in red).

 If month of birth is not available, select “Not Recordable”.  If the number for months is zero, enter “0”, do not leave blank.  Please note the warning if the recorded and calculated ages are in conflict (red box)

 Choose all that apply for this participant

 If the answer to the Jewish Heritage is “No”, continue on to the next question for Family History of IBD.

 If the participant indicates they have Jewish heritage and you select “YES” on the eCRF, you will be asked for more specific information (a dropdown will appear). If Yes

For family history of IBD, select one of the options. No further drop down menus will appear.

At the end of each section you will find a comments section. Please add in any additional information relevant to the section here.

 Once you have completed the eCRF enrollment form, and all information has been recorded, choose “complete” from the dropdown menu and click “save record”  To continue to the next eCRF form click “Save and go to Next Form”

 You can also move between forms by using the menu that appears on the left of the screen.  When you select “unverified” at the end of a form, the circle will become yellow, meaning information is still missing.  A circle will appear red as a default, until you change the form to “complete” or “unverified”

Baseline, Visit 2, Visit 3 and Visit 4

 Enter the clinical data form first before entering any other forms; it needs to be completed prior to completing any of the forms that follow to allow auto-population of specific fields.

 You are initially entering the enrollment visit information, therefore you will choose “baseline”  When you chose the baseline, the date of the visit will pop up for you to enter the information.

 The baseline imaging investigation information requires the date the investigation done, or in the case of pelvic MRI, why it was not done.

Enter the available data and metric conversion will be calculated if needed.

If the participant does not have extra-intestinal manifestations, choose “No”. Continue on to next question.

If the participant has extra-intestinal manifestations, please identify. If you choose “other”, please indicate what in the details box.

 Please identify if the participant does not have perianal disease at baseline and continue on to next form.  Remember to save the information.

 Please identify if the participant has perianal disease at baseline. Make note that if they do, a pelvic MRI should be performed.  Remember to save before going on to next section.

Baseline, Visit 2, Visit 3 and Visit 4

* If blood work was not done at the baseline visit, select “no”. Continue on to next form. * Remember to save the form before you continue on.

 If blood work was done at the baseline visit and you select “yes”, the fields will drop down for you to select.  If specific blood work was not done, select “not done” option.  Note that there are certain values that require you to select the unit type reported as well.

 Some items require you to provide additional information for sample values

 If the blood work values are outside of the standard ranges, you will receive an alert for you to double check the value you have entered.

Baseline only

At the enrollment visit, you must select if you are entering information on a new or established patient Your selection will decide which type of medication information you will need to enter.

This portion of the paper CRF is only for established patients This portion of the paper CRF is for new and established patients

 When you select “established patient, you will be required to fill out the medications taken since diagnosis. You will not see this drop down again in the follow up visits

 When you select “new patient, you will be required to fill out the medications started at diagnosis,

 If you click “yes” to a particular med, you will need to enter the current status of the medication  Note: for new patients, baseline and diagnosis are considered the same time period

 In the case of antibiotics, you will need to indicate if they were given prior to diagnosis.  If so, enter the date

 Once you have completed the medication section and saved it, the button will turn green on the navigation pane

Baseline, Visit 2, Visit 3 and Visit 4

This portion of the paper CRF can be filled out via patient interview and chart review

Select “Surgical Procedures” from the left- hand menu to enter data from the paper CRF into the eCRF Select “baseline” if you are entering information for the enrollment visit If you select “yes” to a surgical procedure, you will need to enter how many procedures were performed, and also provide location information location information

Paper CRF eCRF – this part will only pop up if you’ve indicated in section 2 that a procedure has been performed

Baseline and Visit 4

These fields are automatically calculated Enter the information into the eCRF as it appears on the paper CRF. You must enter a date to be able to enter the eCRF information. Use a ruler to measure the marking of the lines on the paper CRF These markers can be clicked and dragged to the proper place, to match the paper CRF

Continue to enter information from the paper CRF into the eCRF, by clicking and dragging the boxes

When all the information has been entered, change the dropdown box to “complete” and save the record. If information is still missing, select “unverified” from the dropdown box.

Baseline, Visit 2, Visit 3 and Visit 4

Once you select the type of visit, and the date, the fields below are automatically populated by information entered previously Automatically filled in based on date

 The laboratory results will be automatically displayed from the blood work section.  You must select the appropriate result based on the blood work values

Paper CRF eCRF Enter the remainder of the PCDAI information into the eCRF as it appears on the paper CRF

 The PCDAI score will be calculated automatically based on the information you enter.  When it is complete, select “complete” from the dropdown menu and save the record  If the PCDAI is zero, the field will be blank

Baseline, Visit 2, Visit 3 and Visit 4

To enter specimen collection data, you must select “yes” when asked if a specimen was collected

 To enter the sample IDs, you must enter how many aliquots were taken. This is how the information is recorded on the paper CRF

 Once you enter the sample ID, a dropdown will appear allowing you to select the current location of the sample.

 Select “No” and save page as complete.  Move onto next form.

Baseline, Visit 2, Visit 3 and Visit 4

* The disease location form needs to be filled out whenever one of the four procedures listed are performed * If an MRE is performed after 12 months, it can be considered the 18 month visit MRE required for enrollment into the study.

* In the eCRF, if an MRE or lower endoscopy was performed for a particular visit, this will have already been indicated in the “Clinical” form * Based on the information you entered into the “Clinical” form, questions 2.3 and 2.4 will be automatically calculated * If an upper endoscopy or ultrasound was performed, you will need to indicate that here

Paper CRF * The remainder of the eCRF appears identical to the paper CRF. * Enter the information as appropriate

 If you select “yes” that the upper GI tract was assessed, a dropdown will appear to allow you to enter more information.

Baseline, Visit 2, Visit 3 and Visit 4

If an upper or lower endoscopy is performed, the gastroenterologist who performed the procedure will need to fill out the “Endoscopic Scores” form

 Enter applicable data to determine the SES scores.  These are automatically calculated as per entered information. You must select “yes” to be able to enter any corresponding information

 SES scores for Lower GI endoscopy are calculated after all lower GI procedures entered.

 Enter applicable data and SES scores will be calculated here as well.

 Summary SES score for Upper GI will be calculated automatically.

See separate eCRF tutorial on ImageKids Website.

 To be filled out if the patient comes off study after enrollment or if on the baseline portion of the study only.  Choose reason why.