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This page contains up-to-date information clarifying data entry for the CCFA RISK Stratification Project in Clinipace. For any assistance with data entry into Clinipace, contact the Data Coordinating Centre (DCC) at risk_dcc@prokiids.com

ATTENTION:

Avoid selecting “Unavailable/Not Applicable” for fields unless the data truly is missing:

The DCC may query sites for data indicated to be “Unavailable/Not Applicable” in cases where having the data would be highly beneficial.

Avoid selecting “Unavailable” for WF10 (Disease Behavior) questions 38.5/38.7:

Avoid selecting "Unavailable" for WF10 38.5 or 38.7 (“Does the participant now exhibit Stricturing/Fibrostenotic  /  Internally Penetrating disease behavior ?") as this will prevent changes to the disease status status in future visits.

INSTRUCTIONS:

How to indicate that a participant has been lost to follow up in Clinipace:

1)      Click on the "Follow Up Data Capture" link.

2)      Select WF1 "Follow Up Visit Registration".

3)      Select the Site and Subject.

4)      In the first page of WF1 ("Risk Stratification: Visit Information") click on the study visit that is due/outstanding. (i.e. the visit that cannot be performed because the patient is lost to follow up).

5)      Select "Yes" for "Was this follow-up review performed?" Add the date of review (when the review/visit should have happened), and click through to the end of WF1.

6)      Click on WF2 "Confirmation of Diagnosis at Follow Up", select that same study visit, and click through the rest of that WF.

7)      Click on WF3 "Clinical Data at Follow Up" and select that same study visit.

8)      For 33.1 "Are these data taken from a clinic visit?" select "No data are available on this participant for this review".

9)      For 33.2 "Has this Participant been permanently lost to follow-up?" select "Yes".

à Participants that have been indicated to be “lost to follow up” in this way will no longer show up as “outstanding” in our data cleaning queries.

How to indicate that a visit was skipped in Clinipace:

If data for this visit is NOT expected to surface in the future:

1)      Click on the "Follow Up Data Capture" link.

2)      Select WF1 "Follow Up Visit Registration".

3)      Select the Site and Subject.

4)      In the first page of WF1 ("Risk Stratification: Visit Information") click on the study visit that is due/outstanding (i.e. the visit that was skipped).

5)      Lastly, select "No" for "Was this follow-up review performed?"

à You will not be able to fill in any other WFs for that particular visit for that patient (but the data will be carried forward from the previous visit to the next visit correctly).

à Skipped visits recorded in this way will no longer show up as “outstanding” in our data cleaning queries (although this was a problem previously, the problem has now been fixed).

If data for this visit MAY surface in the future:

1)      Click on the "Follow Up Data Capture" link.

2)      Select WF1 "Follow Up Visit Registration".

3)      Select the Site and Subject.

4)      In the first page of WF1 ("Risk Stratification: Visit Information") click on the study visit that is due/outstanding. (i.e. the visit that cannot be performed because the patient is lost to follow up).

5)      Select "Yes" for "Was this follow-up review performed?" Add the date of review (when the review/visit should have happened), and click through to the end of WF1.

6)      Click on WF2 "Confirmation of Diagnosis at Follow Up", select that same study visit, and click through the rest of that WF.

7)      Click on WF3 "Clinical Data at Follow Up" and select that same study visit.

8)      For 33.1 "Are these data taken from a clinic visit?" select "No data are available on this participant for this review".

9)      For 33.2 "Has this Participant been permanently lost to follow-up?" select "No".

à Some coordinators have been recording skipped visits this way even though no data is expected to surface for that visit. This method is also fine, but it requires more work since you have to click through all the WFs for that skipped visit to make sure that the data is carried forward to the next visit correctly.

Saving data entered into WFs safely:

Every time you enter new data into Clinipace, please make sure you click through the entire WF for which you enter data (to make sure it saves correctly and is correctly carried over to future visit WFs). (For example, you open WF3 and enter the study visit month on the first “Visit Information” page and click “Next”. Scroll to the bottom of the verification page and click “Next”. Then answer all the questions and click “Next”. Lastly, scroll to the bottom of the verification page and click “Next”.) Try not to click “Back”, as this may result in some of the data carried forward from a previous visit being lost. (For example, you open the 18 month WF3 “Clinical Data at Follow-Up” and enter the current diagnosis and you also note that the 12 month visit’s diagnosis has been correctly forwarded beneath the statement “At the last review, the subject's diagnosis was recorded as:” You then click “Back” by accident, which takes you to the “Visit Information” verification page. When you click “Next” on that page to return to the “Clinical Data at Follow-Up” page to enter in the height, weight, tanner, etc., the forwarded previous diagnosis under “At the last review, the subject's diagnosis was recorded as:” has now been blanked out..) If a field does not carry forward the data from the previous visit, then the only way to correct it is for the DCC to void the visit WF and the data to be entered again. Note that this method may not prevent all cases of misinformation carry-over.


How to change “un-editable” information entered previously into a WF:

For follow-up data, sometimes you cannot edit information entered into a WF# after it has been saved. In that case, you need to ask the DCC (risk_dcc@prokiids.com) to void that WF# for that visit (please provide the subject ID, visit month and WF# for such cases).

Voiding follow-up WF1:

Any changes to data entered into WF1 requires the WF to be voided and the data re-entered.

Voiding follow-up WF2-15:

Note that if a WF must be voided for a particular visit, then all the information already entered for that WF# for later visits must also be voided and re-entered. (For example, you have entered data into WF3 for visits 6mth through to 54mth for a particular participant. However, you notice a mistake in the WF3 form for visit 36mth that you cannot edit. I would need to void WF3 for visits 36mth through to 54mth, and then you would need to re-enter all that data into WF3 in the correct visit order again.) WF#s that may require this kind of extensive voiding are:

  • WF3 Clinical Data
  • WF5 Family History
  • WF6 EIMs
  • WF7 Medical History
  • WF9 Disease Location
  • WF10 Disease Behavior
  • WF11 Perianal Disease
  • WF13a-f (Medications, Treatments)

How to enter medications/treatments that are unavailable as options in Clinipace:

Sometimes it may be important to log medications/treatments that do not match any Clinipace medication entry options (e.g. entyvio/vedolizumab, stelara/ustekinumab)

1)      Open WF13f, check-mark “Supplemental Other”.

2)      Add the start date

3)      Select “0” for calories

4)      Select an answer (Yes/No) to the question “Is the treatment ongoing?”

5)      Add the stop date (if the treatment is not ongoing)

6)      In the Comments box, include:
-name of treatment/drug
-dose
-any other important info (e.g. frequency)