Im Funded Now What Do I Do

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Session 4

• Im Funded Now What Do I Do?

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What Am I Going To Need To Get The Study Started?
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What Am I Going To Need To Get The Study Started?

• CRFs
• Data management plan
• MOP
• Training

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CRF vs. Source Document

• What is the difference?

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CRF vs. Source Document

• What is the difference?
• Source document contains the records of what
  has happened to the participant
• Hospital charts
• Images
• Laboratory values
• CRF extracted relevant information from the
  source document that will be used in the analysis
  of the data

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Where Do I Start with CRFs?
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Where Do I Start with CRFs?

• Make a list of everything you will ever want to
  know about the participants
• Review the protocol
• Consider ancillary studies
• Consider what journal reviewers will want
• Consider how you will track patients
• Think hard about how likely it is that you will
  analyze each item

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Should You Collect The Same Data More Than Once?
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Should You Collect The Same Data More Than Once?

• Quality assurance check
• Sometimes facilitates the flow and logic of data
• Need to know baseline bowel frequency to
  determine how much the current frequency is
  greater than baseline
• Concomitant medications that are not changing
• Downside may irritate folks who have to enter
  the data
• Data entry screens can be programmed to bring up
  previously entered data

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You need to collect concomitant medications at
each visit. Should you use a new form at each
visit or have a continous form?
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Separate Form For Each Visit
Scan in example form
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Single Continuous FormPage 1
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Single Continuous FormPage 2
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Which Is Better?
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Separate vs. Continuous

• Separate
• Old form as back-up
• Easier data entry
• Continuous
• Less writing for coordinators
• Probably fewer data errors
• More complicated data entry if doing real time
  data entry.
• Less complicated data entry if only entering data
  at conclusion of patients time in the study

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General Principle

• When designing CRFs, need to consider ease of
  recording on form, entering into computer and how
  the data will ultimately be analyzed
• Want to design forms to prevent errors
• Give highest priority to ease of recording on
  form
• Next to those keying data into DMS
• Next to those preparing reports and doing
  analysis

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Other Tips To Help You

• Check boxes rather than blanks when ever possible
• Forms are vertical, not horizontal
• Skip patterns require careful attention
• Who will compete the form
• Patient
• Investigator / coordinator
• Have participating sites review CRFs
• Insist on having forms piloted with real patient
  data at at least a couple of sites prior to
  finalizing
• Other tips?

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How Should Data Be Sent to DCC?
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How Should Data Be Sent to DCC?

• We considered the following
• CRFs
• Fax
• Scanned
• Courier (e.g. FedEx, DHL, etc.)
• Regular or express mail (batched)
• On site data entry

Which of these would you choose and why?
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How Should Data Be Sent to DCC?

• CRFs for centralized data entry
• Fax easy and inexpensive, but more often
  illegible
• Scanned
• PDF - inexpensive, ready for archive, requires
  some degree of computer savvy at sites
• Optical scanning for automatic data entry more
  expensive, more complicated to set up, prone to
  errors
• Courier easy but most expensive
• Mail cheap (regular mail) or expensive (express
  mail) longer time to delivery have originals at
  data center

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How Should Data Be Sent to DCC?

• On site data entry
• Relies on sites for data entry
• Additional training
• Staff doing data entry have other duties, data
  entry may be delayed
• More complicated web portal must be developed
• Staff may enter data on form first, then
  entergood use of site staff time?
• Sometimes sites ignore instructions and write
  notes on CRFs
• Having CRF helps to resolve illogical entries
• Double data entry at site?

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How Should Data Be Sent to DCC?

• We considered the following
• CRFs
• Fax
• Scanned
• Courier
• On site data entry

We went with courier, but all are potentially
viable