Tab 11 - Electronic case report form design.ppt

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Tab 11 - Electronic case report form design.ppt Powered By Docstoc
					                  Electronic CRF Design
Data Management




                          Erik Jolles,
                     Senior Data Manager,
                   Family Health International
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                                                 ICSSC
                                Definitions
                  eCRFs are the electronic representation of paper
                  data collection forms
                  These can be duplicated from paper data
Data Management




                  collection forms or can themselves be the tool
                  that is used for data collection
                      Data Entry screen
                      Data Fax entry screens (OCR,ICR)
                      EDC – Entry screens


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                                                             ICSSC
                     Some general Guidelines

                  eCRFs should be very similar to paper CRFs
                      Should mimic the design and flow of paper CRF
Data Management




                  eCRFs should have built-in edit checks tagged to
                  each data field and also tagged to the form as a
                  whole
                  If there are no paper CRFs majority of the data
                  cleaning will take place during the completion of
                  the eCRFs.

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                                                             ICSSC
                          Things to Consider

                  Ease of entry
                  Avoid over crowding
Data Management




                  Match electronic form to paper form as much as
                  possible
                  Use of pre-coded answer sets
                  Avoid excessive use of text fields
                  AE designs


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                                                           ICSSC
                  Ease of data entry
Data Management




                                               5



                                       ICSSC
                  Pre-coded Answer Sets
Data Management




                                                  6



                                          ICSSC
                  Radio Buttons
Data Management




                                          7



                                  ICSSC
                  Check Boxes
Data Management




                                        8



                                ICSSC
                                   Dates

                  Dates can be designed to be entered as a single
                  item; however, you may have problems with
Data Management




                  incomplete dates
                  FHI uses separate items for each part of the
                  date and a derivation to get the date
                  We also need to keep in mind the format that
                  the dates will be collected (e.g., dd/mm/yyyy,
                  mm/dd/yyyy, dd/mon/yyyy) and set up the
                  screens appropriately.

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                                                            ICSSC
                  Repeating Records
Data Management




                                          10



                                      ICSSC
                  Text Fields
Data Management




                                    11



                                ICSSC
                  Text Fields (2)
Data Management




                                        12



                                    ICSSC
                           Testing of eCRFs

                  eCRFs should be tested for ease of entry and
                  data cleaning programs
Data Management




                  Electronic check
                  Tab order
                  Order of items on the form
                  Answer sets (code lists)




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                                                            ICSSC
                            Tools for testing

                  Test data – to test error specifications and train
                  data entry staff
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                  Data base specifications
                  List of tables
                  Error specification document
                  Variables and formats in each table
                  List of pre-coded answer sets (codelists)
                  Expected error matrix

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                                                              ICSSC
                               Conclusions

                  Design eCRFs as you would paper CRFs
                  Error checks should be tested for each eCRF and
Data Management




                  tested with test data
                  eCRF should be reviewed not only by study team
                  but also by data entry staff
                  Store documentation of for the design of the
                  eCRFs



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                                                           ICSSC