WORK INSTRUCTION WI-DCC-0004 Date Title: … Page 1 of 16 WORK INSTRUCTION WI-DCC-0004 Version: V1...

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WORK INSTRUCTION WI-DCC-0004 Version: V1 Date: 25th-June-2010 Title: Inputting Paper CRF into the Database Referenced SOP: SOP-DCC-0005 (Data Entry and Verification) Approved: Etienne Grima, COO, Data Coordination Centre Signature: __________ Date: January 31, 2011 Intended Audience: Anyone who has some knowledge of TeleForm Verification software Prerequisite: NA PROCEDURES: These instructions cover the following:

1. Scanning paper CRFs 2. Importing faxed CRF images 3. Quality Control (QC) on CRF images 4. Verification 5. Double data entry 6. Manual data entry

1. Scanning paper CRFs 1. Group the paper CRFs based on the study name. 2. Check the “BATCH TRACKING ID ASSIGNMENT SHEET” (See Fig 1) and assign a

Batch Tracking ID for the CRFs that will be scanned on that day. This Batch Tracking ID will remain the same for all the CRFs scanned into the TeleForm system on that day for that particular study.

3. On the “BATCH TRACKING SHEET” (See Fig 2) enter Date, Batch Tracking ID, Site IDs and Patient IDs of the CRFs and the total number of CRFs images in the batch. Due to the limitations of the scanner, thirty (30) or less CRFs per batch/scanning session is recommended.

4. Switch on the Scanner. 5. Double click on the “TeleForm MONITOR” icon, minimize the window. 6. Double click on the “TeleForm READER” icon, minimize the window. 7. Double click on the “TeleForm SCAN STATION” icon and log on. 8. Place the paper CRFs on the Scanner, face down. 9. Click on File -> New Batch on the “TeleForm SCAN STATION” window. 10. A batch number will be generated by the TeleForm system. This number will appear on the

top left corner of the window. (E.g. TeleForm Scan Station – [00012272 – Batch is being created]).


Record this batch number in the BATCH TRACKING SHEET’s Batch Number column. 11. Click on the “Process” tab (See Fig 3) -> in the “Source” box -> select “FUJITSU f2-4340

Cd #3” -> in the “Settings” box -> select [Default] -> in the “Feeder” box -> select “Front only”.

12. Click on the “Details” tab (See Fig 4) -> under the “General” section -> in the “Job” box -> select “Regular Batches From Scanner”.

13. In the “Tracking ID” box -> enter the assigned Batch Tracking ID. 14. In the “Operator” box -> enter operator’s name. 15. Under “Advanced” section in the “priority” box -> select priority 100. 16. In the “Pages expected” box -> select “1”. 17. In the “Error handling” box -> select “Prompt for action”. 18. In the “Forms expected” box -> select “0”. 19. Click on the “Start” button to activate the scanning process. 20. When the scanning is completed -> click on the “Accept” button (See Fig 5). Check whether

the number indicated in the “Total pages in batch” box in the “Accept/Reject Batch” window (See Fig 6) is the same as the actual number of paper CRFs scanned. If there is no discrepancy -> click on the “Accept” button

If there’s a discrepancy, discard the batch by clicking on the “Discard” button and repeat the process starting from Step 8.

21. Repeat the process starting from Step 8 until the scanning of all the paper CRFs pertaining to that study is completed.

22. When the scanning procedure is completed, perform Quality Control (QC) functions on the newly created batches to prepare the batches for further processing at the Verification stage (See page 8).

Fig 1


Fig 2 Fig 3


Fig 4

Fig 5


Fig 6


2. Importing faxed CRF images 1 Check the “BATCH TRACKING ID ASSIGNMENT SHEET” (See Fig 1) and assign a

Batch Tracking ID for the CRF images that will be imported into the TeleForm system on that day. This Batch tracking ID will remain the same for all the CRF images imported into the TeleForm system on that day for that particular study.

2. On the “BATCH TRACKING SHEET” (See Fig 2) enter Date, Batch Tracking ID. 3. Click on Start -> My documents -> Test Images -> Pending Faxes for DCC -> Study ABC. 4. Copy the fax image/s -> Go back x2 -> Paste the image in the “Test images” folder outside

“Pending Faxes for DCC” folder. 5. Open “TeleForm SCAN STATION” -> click on File -> New Batch. 6. A Batch number will be generated by the TeleForm system. This number will appear on the

top left corner of the window. (E.g.: TeleForm Scan Station – [00012275 – Batch is being created]).

Record this batch number and also the number of faxes in the batch, total number of CRF images in the batch – obtained after QC (see page 8) on the BATCH TRACKING SHEET.

7. Click on the “Process” tab (See Fig 7) -> in the “Source” box -> select “Directory” -> in the “Directory” box -> select the correct directory path.

(E.g.: c:\Documents and settings\DCC\My Documents\Test images\). 8. In the “Order by” box -> select “[None]”. 9. In the “Pattern” box -> enter “*.TIF”. 10. Click on the “Details” tab (See Fig 8) and under the “General” section in the “Job” box ->

select “Regular Batches, From Directory FTP”. 11. In the “Tracking ID” box -> enter the assigned Batch Tracking ID. 12. In the “Operator” box -> enter operator’s name. 13. Under “Advanced” section in the “Priority” box -> select “100”. 14. In the “Pages expected” box -> select “0”. 15. In the “Error handling” box -> select “prompt for action”. 16. In the “Forms expected” box -> select “0”. 17. In the “Description” box -> enter “Regular From Directory”. 18. Click on Start to activate the importing images process. 19. When the importing procedure is completed -> click on the “Accept” button.. 20. Minimize TeleForm Scan Station [Batch explorer] window. 21. Create a folder named “(name of the study) imported dd/mmm/yyyy”. Note: one folder per

study per day. 22. Move the fax images sitting in the Test images folder into this folder. 23. Repeat the process starting from Step 3 until the importing of all the faxed images pertaining

to that study are completed. 24. When the importing procedure is completed, perform Quality Control (QC) functions on

the newly created batches to prepare the batches for further processing at Verification stage (see page 8).

25. At the end of the day move the folder named “(name of the study) imported dd/mmm/yyyy” into the backup/storage folder “CRFs imported into the TeleForm” created in the file server ‘P’ drive.


Fig 7

Fig 8


3. Quality Control (QC) on CRF images 1. Double click open the TeleForm Verifier and log on. 2. In the TeleForm Verifier window -> click on Utilities -> select “Batch Management”. 3. In the “Batch Management Dialog” window when the status of the scanned/or imported

batch is indicated as “Ready for classification QC”, (See Fig 9) right click on the batch and select “QC” (See Fig 10).

4. In the “Any time QC” window if unclassified forms are indicated under “Classification and Indexing” section -> click on “Unclassified” to bring up the images of Unclassified/Non-forms. (See Fig 11) If no unclassified forms -> go to Step 8.

5. Right click on the non-CRFs (E.g. images of CVs, cover sheets) if there are any, and delete those images from the batch.

6. Right click on the Non Form and select “Classification” -> “Evaluate As” (See Fig 12) and evaluate the forms according to the study and page/title identification (See Fig 13) -> click “OK”.

7. Continue the process 6 until “Unclassified” shows (0), (See Fig 14). 8. Click on File -> Close -> select “Save changes and release batch for further processing” -> click OK (See Fig 15). 9. In the TeleForm Verifier – [Batch Management Dialog] window, when the status of the

batch is indicated as “Ready for correction”, (See Fig 16) the batch is ready for correction/verification.

10. Enter the Batch information (i.e. Batch Number, Number of pages, Project name, Scanned/Imported/BW [Batch Watcher for duplications] date) on the “BATCH

ASSIGNMENT” (See Fig 17) sheet in the “Shared Folder”. Fig 9


Fig 10

Fig 11


Fig 12

Fig 13


Fig 14

Fig 15


Fig 16

Fig 17


4. Verification 1. Open the TeleForm Verifier and log on. 2. In the TeleForm verifier window -> click on “Utilities” -> select “Image Management

Dialog”. 3. In the TeleForm Verifier – [Image Management Dialog] window under the “Batch”

section -> click on the down arrow -> click on the correct batch number to open up the batch (See Fig 18).

4. If the image of the CRF is not displayed on the screen -> click on the “Form Mode” button to bring up the CRF image (See Fig 19).

5. On the CRF image (See Fig 20) tab cell to cell and check whether the data is captured correctly. If not, make the necessary corrections.

6. When the last data field of that CRF is corrected/verified -> “Save corrections to the results file”? box will appear -> click “Yes” to save the corrected/verified data.

7. Repeat the process from Step 4-6 until all the CRFs in the batch are corrected/verified. 8. When the status of the batch is indicated as “Evaluated OK” (See Fig 21) -> click on the

“Properties…” button (See Fig 21) to bring up the “Batch Properties” window (See Fig 22).

9. In the “ Batch Properties” window -> click on the down arrow next to “Action/Refresh” button -> click on “Commit” to save the data into the database.

10. Enter the Data Entry personnel’s name and batch completion date in the “BATCH ASSIGNMENT SHEET” (See Fig 17) in the “Shared Folder”. Fig 18


Fig 19 Fig 20


Fig 21 Fig 22


5. Double data entry

1. Log into the website of the given study. 2. Use specified username and ID. 3. Check the number of paper CRFs entered or verified by the first entry to the number of forms

in the pending list (under page name). 4. Compare the form layout of the electronic CRF (left side) to the original CRF (right side) to

ensure that they are the same. 5. Enter values as seen on the paper CRF into the electronic CRF. 6. After completion of the form -> click on Save. 7. The form is automatically removed from the pending entry list (page name) after completion. 8. Go on to the next form in the pending list and repeat Steps 4-6. 9. After the second data entry of a CRF is completed, to exit the double data entry system ->

click on Exit. 6. Manual data entry 1. Record the Date, Batch number, Site number, Patient number, Patient initials, Page ID

number/visit number and Data Entry personnel’s name on the correct Manual Data Entry Log (Separate studies will have separate MDE Logs).

2. Log on to the TeleForm Verifier. 3. Click on “Utilities” -> select “NonForm Data Entry…”. 4. In the “Select Template(s)” window -> select the correct Study, Title/Form ID -> Click

OK. This step will bring up the Template onto the screen. 5. Enter data extracted from the CRF into the Template. 6. When the last data field is entered, question “Save corrections to result file?” appears ->

Click OK to save the data into the database.

WORK INSTRUCTION WI-DCC-0004 Date Title: … Page 1 of 16 WORK INSTRUCTION WI-DCC-0004 Version: V1...

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