1. Archiving Study Information Sjouke Huisman Thorin BV e-mail: Sjouke.Huisman@Thorin.nl

2. Contents of PDF Archive CRF images Discrepancies between CRFs and Data –Approved corrections –QC reports Additional information –QC process –Audit Trail –Lab information –Study Documents

3. Methods for Archiving (1) DFpdf: most suitable for archiving (only) CRF images on a Patient by Patient basis –Customize Visit & Plate labels –Select & Sort records –Specify Title & Page Header + Footer –Allows fields to be blinded

4. Methods for Archiving (2) Custom built: any combination of DataFax utilities, Unix scripting and third-party software +Combine with any source of information +Allows restructuring of output +User-specified Bookmarking -Time consuming to program/validate

5. Mismatch CRF Data (1) CRF image is not always full story Minor updates, based on Approved Corrections –e.g. Local language dates (01/MAA/2009 -> 01/MAR/2009), Typo in Initials, etc. Set Standard for documenting; and include old/new value: (Reason: AC08; 01/MAA/2009 -> 01/MAR/2009) Allows to retrieve all ACs, for Inclusion in PDF Archive; or approval by Site

6. Mismatch CRF Data (2) Or the Q&A section explains the mismatch Document the process in Query: Add QC report ID to Note field (see 456-090225, page 3) Decide upfront if reply on Fax/Refax section is allowed. Query Field might get updated for new Query

7. Audit Trail Archiving More than one client was interested in Audit Trail listing Separate listings for Data or Queries Post process Editing of output Think about presentation: –Default: by patient/page & time –Point of Entry might be a given Field

8. Audit Trail Processing Audit trail processing (DF_ATmods) can be very demanding All updates on Field=X of Page=Y of Patient=Z, will require all Journal files records to be processed Separate listings per page, multiplies processing time with N=Pages In a large study, we had to execute DFaudittrace once and split output into separate files per page

9. Other Sources of Information Custom design allows to combine with other (external) sources; e.g. Lab Forms Study documents: Annotated CRF, Study protocol, etc. DFprintdb to print actual data on CRF Include information from Lost Data Log Monitor reports, etc.

10. Append PDF pages After collecting and converting all information (Sun raster -> PDF), it needs to be appended into one or more PDF files Think about structure: –Single PDF per study, or –per Site, or –per Patient, or –per Page Think about Filename conventions

11. Bookmark The more complex the Archive, the more essential the Bookmarking Our requirements: –Available for Solaris –Ability to execute in Batch mode –Optionally: ability to reference external PDF files –(cost and speed)

12. Third party Software Started with AppendPDF (and PDFbookmark), it looked promising, but… Decided for PDFmeld (www.fytek.com): –Append/Combine PDF/Text files into single PDF –Overlay pages and set transparency, or perform 2- up imposition (data + image) –Add Stamps, Headers & Footers, Page numbers, Password protection –Can only Bookmark within PDF

13. Conclusion Have the Archive in mind when running a Study Retrieval of historic information from Audit Trail can be facilitated by standardizing Queries/Reasons Custom built Bookmarks essential for complex Archives

14. An Example In the following example, we have used: 1.DFexport to extract the data and print on the CRF images using DFprintdb 2.DFimageio, DFpsprint and Acrobat Distiller to create a PDF of CRF images 3.PDFmeld to link each field on the DATA image to an extract from the Audit Trail; and created links to Q&A sections of the QC reports

15. An Example (Continued) 4.PDFMeld to link the CRF image to Secondary pages 5.PDFmeld to add PDFnotes on Approved Corrections to the CRF image 6.PDFmeld to rescale the CRF image to match the DATA image 7.PDFmeld to concatenate the CRF part to the DATA part 8.PDFmeld to Bookmark the PDF file

16. Archive Demo Please click on PDF ARCHIVE to open the Demo filePDF ARCHIVE NOTE: –This is not the actual output from our Archiving program, but an example of what might be possible –On page 1, click on DUPL1 or DUPL2 to open earlier faxed CRF pages (Duplicate copy), or –On page 1, click on QC1 to open a QC report which has been returned by a site for this CRF page, or –On page 1, click on the Green Note, to see the text of the Approved Correction, or –On page 1, click on Date of Pregnancy test to see the Audit Trail for that item –Only bookmark for Site NL001, Subject 99001 is implemented