Label for use in blind clinical studies of a medicament

Claim 2

A label, for use in blind clinical studies of a medicament: formed from a blank having a succession of at least three adjoining panels which are folded along the panel junction lines so that the first panel overlays the second panel and the third panel underlays the second panel; medicament-identifying indicia on the original front side of the second panel and substantially solid ink on the original front side of the first and third panels so that when the first and third panels are folded to overlay and underlay, respectively, the second panel, the medicament identifying indicia on the second panel not only is covered and so rendered invisible, but also is not readable by holding the folded label against a light; other indicia, representative of the single patient being administered the medicament with which the label has been associated, and not of a character to identify the medicament to the clinician, either on the original back side of the first panel or on the original front side of the fourth panel adjoining the third panel, the fourth panel, when present, being folded over the original back side of the first panel when the latter is folded over the second panel, in either case the other indicia being the indicia exposed on the front of the folded label; and means adhesively securing said panels in folded position while maintaining free from adhesive the portion of the original front side of the second panel on which the medicament identifying indicia is printed, so that the clinician may, if necessary, cut along the junction line between the first and second panels and readily pull forward the second panel from the first panel to expose the medicament identifying indicia for the single patient being administered the medicament associated with the label.

Claim 3

An assembled label as set forth in claim 1 in which the blank has an additional panel adjoining the side of the second panel, the original front side of the additional panel having thereon indicia substantially corresponding to the other indicia, the original back side of the additional panel being adhesively secured to the container containing the medicament to be clinically tested and the additional panel having a tear line at or near the junction line between the additional panel and the second panel, at which tear line the remaining portion of the assembled label may be separated from the portion of the label secured to the container so that the separated portion may be readily kept with the medical records for the specific patient identified by the other indicia.

Claim 4

A label, for use in blind clinical studies of a medicament, formed from a blank having a succession at at least four adjoining panels which are folded along the panel junction lines so that the first panel overlays the second panel, the third panel underlays the second panel, and the fourth panel overlays the first and second panels together, the blank also having an additional panel adjoining the side of the second panel; medicament-identifying indicia printed on the original front side of the second panel and substantially solid ink printed on the original front side of the first and third panels so that when the first and third panels are folded to overlay and underlay, respectively, the second panel, the medicament identifying indicia on the second panel not only is covered and so rendered invisible, but also is not readable by holding the folded label against a light and also is protected from examination of the original back side of the second panel for any deformation of the label stock caused by printing the medicament identifying indicia on the original front side thereof; other indicia representative of the single patient to be administered the medicament with which the label is associated, and not of a character to identify the medicament to the clinician, printed on the original front side of the fourth panel and on the original front side of the additional panel, this other indicia thus being the indicia exposed to the clinician after the label is fully folded; means adhesively securing the succession of panels in folded position while maintaining free from adhesive the portion of the original front side of the second panel on which the medicament identifying indicia is printed; adhesive securing the original back side of the additional panel to the container containing the medicament to be clinically tested; and the additional panel having a tear line at or near the junction line between the additional panel and the second panel, at which tear line the remaining portion of the assembled label may be separated from the portion of the label secured to the container so that the separated portion may be readily kept with the medical records for the specific patient identified by the other indicia; this separated portion, after being cut by the clinician, when necessary to do so, along the junction line between the first and second panels, enabling the clinician to readily pull forward the second panel from the first panel to expose the medicament-identifying indicia printed on the second panel for the single patient being administered the medicament in the associated container, without exposing to the clinician the medicament-identifying indicia for any other patient in the same blind clinical study.

Claim 5

A label, for use in blind clinical studies of a medicament, formed from a blank having a succession at at least four adjoining panels which are folded along the panel junction lines so that the first panel overlays the second panel, the third panel underlays the second panel, and the fourth panel overlays the first and second panels together, the blank also having an additional panel adjoining the side of the second panel; medicament-identifying indicia printed on the original front side of the second panel and substantially solid ink printed on the original front side of the first and third panels so that when the first and third panels are folded to overlay and underlay, respectively, the second panel, the medicament identifying indicia on the second panel not only is covered and so rendered invisible, but also is not readable by holding the folded label against a light and also is protected from examination of the original back side of the second panel for any deformation of the label stock caused by printing the medicament identifying indicia on the original front side thereof; other indicia representative of the single patient to be administered the medicament with which the label is associated, and not of a character to identify the medicament to the clinician, printed on the original front side of the fourth panel and on the original front side of the additional panel, this other indicia thus being the indicia exposed to the clinician after the label is fully folded; means adhesively securing the succession of panels in folded position while maintaining free from adhesive the portion of the original front side of the second panel on which the medicament identifying indicia is printed; adhesive securing the original back side of the additional panel to the container containing the medicament to be clinically tested; and the additional panel having a tear line at or near the junction line between the additional panel and the second panel, at which tear line the remaining portion of the assembled label may be separated from the portion of the label secured to the container so that the separated portion may be readily kept with the medical records for the specific patient identified by the other indicia; this separated portion, after being cut by the clinician, when necessary to do so, along the junction line between the first and second panels, enabling the clinician to readily pull forward the second panel from the first panel to expose the medicament-identifying indicia printed on the second panel for the single patient being administered the medicament in the associated container, without exposing to the clinician the medicament-identifying indicia for any other patient in the same blind clinical study.

Claim 6

The label as set forth in claim 3 in which the blank has a fifth panel in the succession of panels and a stub panel positioned along the side of the second panel opposite the side along which the additional panel is positioned; the stub panel being folded forward over the original back side of the first panel after the latter is folded forward to overlay the second panel, and the fifth panel being folded back to underlay the third panel after the fourth panel is folded forward to overlay the second and first panels together; and the adhesive of the adhesive means for securing the panels in folded position being applied along the side of the original front side of the first panel nearest the additional panel, over the original front side of the stub panel, along the sides of the original back side of the third and fourth panels, and over the original back side of the fifth panel.

Claim 7

The label as set forth in claim 3 in which the adhesive means includes a heat sensitive coating on the back side of the blank that can be activated upon the application of heat and pressure to the folded succession of panels to secure them in their folded positions, the first panel being slightly smaller than the second panel so that the original back side of the fourth panel is adhesively secured to the original front side of the second panel around the perimeter of the second panel not covered by the first panel when folded to overlay the second panel.

Claim 8

A plurality of labels, one for each container of material to be administered to patients in a blind clinical study of a medicament, wherein the clinician is not to be advised which containers contain the medicament in a certain amount, which containers contain a placebo, and also, if desired, which containers contain the medicament in another amount, each such label having a package portion secured to the associated container and a separable file portion for inclusion with the medical records of the specific patient being administered the contents of the container to which was secured the corresponding package portion of the label, the file portion of each such label bearing, in a concealed manner, the identification of the contents of the container to which was secured the corresponding package portion of the label, so that the clinician may, when medically necessary for a specific patient, ascertain by appropriate mutilation of the file portion of the label for that patient, the identity and amount of the material being administered to that patient, without ascertaining the identity and amount of the material being administered to any other patient in the blind clinical study; characterized in that: each label is formed from a flat blank having a printable front side and a heat sensitive coating on its back side that can be activated upon the application of heat and pressure thereto; the blank having a succession of four substantially rectangular panels adjoining one another along their long sides and having a fifth substantially rectangular panel with one of its short sides adjoining one of the short sides of the second panel, the second, third and fourth panels being of substantially equal size and the first panel being slightly smaller than the second panel, and the fifth panel being separable from the second panel along a tear line at or near the junction line between the fifth and second panels; medicament-identifying indicia being printed on the printable side of the second panel; other indicia representative of the single patient to be administered the medicament with which the label is associated, and not of a character to identify the medicament to the clinician, being printed on the printable side of the fourth panel and on the printable side of the fifth panel; substantially solid ink printed on the printable side of the first and third panels; the first panel being folded forward along its junction line with the second panel to overlay the second panel, the third and fourth panels being folded rearward along the junction line of the third panel with the second panel so that the third panel underlays the second panel, and the fourth panel being then folded forward along its junction line with the third panel to overlay the first and second panels together; the first four panels of the label being adhesively secured in folded, assembled portion by activation of the heat sensitive coating on the original back sides of those panels and constituting the file portion of the label; and the fifth panel being adhesively secured to the appropriate container by activation of the heat sensitive coating on the original back side of that panel, so that the fifth panel constitutes the package portion of the label.

Claim 9

A plurality of labels, one for each container of material to be administered to patients in a blind clinical study of a medicament, wherein the clinician is not to be advised which containers contain the medicament in a certain amount, which containers contain a placebo, and also, if desired, which containers contain the medicament in another amount, each such label having a package portion secured to the associated container and a separable file portion for inclusion with the medical records of the specific patient being administered the contents of the container to which was secured the corresponding package portion of the label, the file portion of each such label bearing, in a concealed manner, the identification of the contents of the container to which was secured the corresponding package portion of the label, so that the clinician may, when medically necessary for a specific patient, ascertain by appropriate mutilation of the file portion of the label for that patient, the identity and amount of the material being administered to that patient, without ascertaining the identity and amount of the material being administered to any other patient in the blind clinical study; characterized in that: each label is formed from a flat blank having a printable front side and a heat sensitive coating on its back side that can be activated upon the application of heat and pressure thereto; the blank having a succession of four substantially rectangular panels adjoining one another along their long sides and having a fifth substantially rectangular panel with one of its short sides adjoining one of the short sides of the second panel, the second, third and fourth panels being of substantially equal size and the first panel being slightly smaller than the second panel, and the fifth panel being separable from the second panel along a tear line at or near the junction line between the fifth and second panels; medicament-identifying indicia being printed on the printable side of the second panel; other indicia representative of the single patient to be administered the medicament with which the label is associated, and not of a character to identify the medicament to the clinician, being printed on the printable side of the fourth panel and on the printable side of the fifth panel; substantially solid ink printed on the printable side of the first and third panels; the first panel being folded forward along its junction line with the second panel to overlay the second panel, the third and fourth panels being folded rearward along the junction line of the third panel with the second panel so that the third panel underlays the second panel, and the fourth panel being then folded forward along its junction line with the third panel to overlay the first and second panels together; the first four panels of the label being adhesively secured in folded, assembled portion by activation of the heat sensitive coating on the original back sides of those panels and constituting the file portion of the label; and the fifth panel being adhesively secured to the appropriate container by activation of the heat sensitive coating on the original back side of that panel, so that the fifth panel constitutes the package portion of the label.