Certified Copy Stamp
In almost every study some data are collected
contemporaneously by direct observation or subject interview; for example,
subject exclusion criteria. These data may be entered directly onto a case
report form. The difficulties with direct case report form entry are that 1)
there is no way to "source" the data, since the case report form is the
source document, and 2) once you remove the case report form from the
investigative site there is no information at the site to support the case
report form entries. One strategy is to make a photocopy of the case report
form, stamp it as a Certified Copy, then sign and date. Either the original
source document/case report form or the Certified Copy may remain at the
investigative site. Certified Copy stamps, pre-inked with red ink, 5/8" x 1
3/4" footprint, are now available from CDG. |
