[ { "page": 1, "items": [ { "page": 1, "type": "TEXT", "location": { "l": 149.76, "t": 666.48, "r": 461.52, "b": 634.56 }, "text": "Modification Request Form\nKentucky State University • Institutional Review Board (IRB)", "links": [ { "uri": "https://www.kysu.edu/academics/research-and-innovation/irb", "dest": null, "action_type": "/URI", "bbox": [ 299.4008, 635.3812, 459.2527, 648.8812 ] } ], "reading_order": 0 }, { "page": 1, "type": "TEXT", "location": { "l": 37.44, "t": 625.68, "r": 570.96, "b": 605.28 }, "text": "PI Name:", "reading_order": 1 }, { "page": 1, "type": "FORM_FIELD", "location": { "l": 94, "t": 622.3812, "r": 304, "b": 606.3812 }, "text": "Principal Investigator name", "field_kind": "text", "label": "Principal Investigator name", "pdf_field_name": "pi_name", "pdf_field_type": "Text", "reading_order": 2 }, { "page": 1, "type": "FORM_FIELD", "location": { "l": 380, "t": 622.3812, "r": 570, "b": 606.3812 }, "text": "IRB protocol number", "field_kind": "text", "label": "IRB protocol number", "pdf_field_name": "irb_number", "pdf_field_type": "Text", "reading_order": 3 }, { "page": 1, "type": "TEXT", "location": { "l": 340.08, "t": 621.36, "r": 569.28, "b": 606.48 }, "text": "IRB #:", "reading_order": 4 }, { "page": 1, "type": "TEXT", "location": { "l": 340.56, "t": 619.44, "r": 371.28, "b": 607.92 }, "text": "IRB #:", "reading_order": 5 }, { "page": 1, "type": "TITLE", "location": { "l": 56.16, "t": 577.2, "r": 122.64, "b": 564 }, "text": "Instructions", "reading_order": 6, "level": 2 }, { "page": 1, "type": "TEXT", "location": { "l": 55.44, "t": 551.76, "r": 306.48, "b": 539.04 }, "text": "Use this form to request IRB approval of the following:", "reading_order": 7 }, { "page": 1, "type": "TEXT", "location": { "l": 56.16, "t": 536.4, "r": 316.08, "b": 524.88 }, "text": "Proposed changes to your current IRB-approved protocol.", "reading_order": 8 }, { "page": 1, "type": "TEXT", "location": { "l": 56.64, "t": 523.68, "r": 561.12, "b": 498.96 }, "text": "A proposed change which impacts an individual subject but does not change the overall protocol (i.e., exception and deviation).", "reading_order": 9 }, { "page": 1, "type": "TITLE", "location": { "l": 56.16, "t": 489.36, "r": 160.56, "b": 477.84 }, "text": "Do NOT use this form:", "reading_order": 10, "level": 3 }, { "page": 1, "type": "TEXT", "location": { "l": 56.4, "t": 475.44, "r": 530.88, "b": 450.72 }, "text": "To report a change to the currently approved protocol which has already been implemented without prior IRB approval.", "reading_order": 11 }, { "page": 1, "type": "TEXT", "location": { "l": 57.6, "t": 448.32, "r": 546.96, "b": 424.8 }, "text": "In emergency situations involving unanticipated problems involving risk to human subjects or others (contact ORI staff immediately at 502-597-6530).", "reading_order": 12 }, { "page": 1, "type": "TEXT", "location": { "l": 56.88, "t": 422.88, "r": 393.12, "b": 410.16 }, "text": "To close a study or to report that a study has been completed (contact ORI).", "reading_order": 13 }, { "page": 1, "type": "TITLE", "location": { "l": 55.68, "t": 400.8, "r": 146.16, "b": 389.52 }, "text": "Please be sure to...", "reading_order": 14, "level": 3 }, { "page": 1, "type": "LIST_ITEM", "location": { "l": 56.4, "t": 387.12, "r": 406.56, "b": 374.64 }, "text": "Revise consent and assent forms, as needed, based on the proposed changes.", "marker": "•", "list_id": "L1", "level": 0, "reading_order": 15 }, { "page": 1, "type": "LIST_ITEM", "location": { "l": 57.84, "t": 372.96, "r": 241.68, "b": 361.44 }, "text": "Complete and attach appropriate forms.", "list_id": "L1", "level": 0, "reading_order": 16 }, { "page": 1, "type": "LIST_ITEM", "location": { "l": 57.6, "t": 359.76, "r": 495.84, "b": 336 }, "text": "If you are adding new study personnel, confirm that all new members have completed the mandatory human-subject-protections CITI training BEFORE you submit your modification request.", "list_id": "L1", "level": 0, "reading_order": 17 }, { "page": 1, "type": "LIST_ITEM", "location": { "l": 57.36, "t": 333.84, "r": 372, "b": 321.6 }, "text": "Have the PI sign on the line provided at the top of the form (next page).", "list_id": "L1", "level": 0, "reading_order": 18 }, { "page": 1, "type": "LIST_ITEM", "location": { "l": 57.12, "t": 320.64, "r": 552, "b": 295.92 }, "text": "Attach two copies – one marked and one clean – of all documents affected by the modification (i.e., consent form). On the track-changes copy, underline or highlight each change being made.", "marker": "•", "list_id": "L1", "level": 0, "reading_order": 19 }, { "page": 1, "type": "LIST_ITEM", "location": { "l": 56.64, "t": 294.48, "r": 524.88, "b": 269.76 }, "text": "Allow ample time for processing this modification request. NOTE: changes may not be implemented prior to receiving IRB approval.", "list_id": "L1", "level": 0, "reading_order": 20 } ] }, { "page": 2, "items": [ { "page": 2, "type": "TITLE", "location": { "l": 40.8, "t": 656.64, "r": 98.88, "b": 644.64 }, "text": "PI Signature", "reading_order": 0, "level": 2 }, { "page": 2, "type": "TEXT", "location": { "l": 39.36, "t": 655.92, "r": 394.08, "b": 644.16 }, "text": "The quick brown fox jumps over the lazy dog.", "reading_order": 1 }, { "page": 2, "type": "TEXT", "location": { "l": 372.96, "t": 655.92, "r": 396, "b": 645.36 }, "text": "Date", "reading_order": 2 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 42, "t": 639.5514, "r": 354, "b": 609.5514 }, "text": "PI signature", "field_kind": "text", "label": "PI signature", "pdf_field_name": "pi_signature", "pdf_field_type": "Text", "reading_order": 3 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 374, "t": 639.5514, "r": 570, "b": 609.5514 }, "text": "Date", "field_kind": "text", "label": "Date", "pdf_field_name": "sig_date", "pdf_field_type": "Text", "reading_order": 4 }, { "page": 2, "type": "TITLE", "location": { "l": 56.16, "t": 587.28, "r": 163.68, "b": 574.08 }, "text": "Modification Details", "reading_order": 5, "level": 2 }, { "page": 2, "type": "FIGURE", "location": { "l": 52.8, "t": 565.92, "r": 66.72, "b": 550.8 }, "text": "", "reading_order": 6 }, { "page": 2, "type": "TITLE", "location": { "l": 52.08, "t": 564.72, "r": 290.16, "b": 552.24 }, "text": "1 Address change for protocol correspondence?", "reading_order": 7, "level": 2 }, { "page": 2, "type": "TEXT", "location": { "l": 74.64, "t": 547.92, "r": 192, "b": 536.88 }, "text": "If yes, indicate new address:", "reading_order": 8 }, { "page": 2, "type": "FIGURE", "location": { "l": 308.88, "t": 567.12, "r": 322.8, "b": 553.68 }, "text": "", "reading_order": 9 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 310.211, "t": 566.5514, "r": 322.211, "b": 554.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q1_address", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 10 }, { "page": 2, "type": "TEXT", "location": { "l": 325.68, "t": 565.2, "r": 345.36, "b": 554.16 }, "text": "Yes", "reading_order": 11 }, { "page": 2, "type": "FIGURE", "location": { "l": 378.72, "t": 567.36, "r": 392.88, "b": 553.44 }, "text": "", "reading_order": 12 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 380.211, "t": 566.5514, "r": 392.211, "b": 554.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q1_address", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 13 }, { "page": 2, "type": "TEXT", "location": { "l": 378.96, "t": 567.12, "r": 410.88, "b": 553.68 }, "text": "6 No", "reading_order": 14 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 204, "t": 550.5514, "r": 564, "b": 535.5514 }, "text": "New address", "field_kind": "text", "label": "New address", "pdf_field_name": "q1_new_address", "pdf_field_type": "Text", "reading_order": 15 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 137.7275, "t": 524.5514, "r": 564, "b": 509.5514 }, "text": "Study title", "field_kind": "text", "label": "Study title", "pdf_field_name": "study_title", "pdf_field_type": "Text", "reading_order": 16 }, { "page": 2, "type": "TITLE", "location": { "l": 50.88, "t": 524.16, "r": 130.32, "b": 509.76 }, "text": "2 Study Title:", "reading_order": 17, "level": 2 }, { "page": 2, "type": "TEXT", "location": { "l": 74.64, "t": 502.56, "r": 134.88, "b": 491.04 }, "text": "Title change?\n6 Yes", "reading_order": 18 }, { "page": 2, "type": "TEXT", "location": { "l": 152.16, "t": 505.44, "r": 189.36, "b": 491.52 }, "text": "6 Yes", "reading_order": 19 }, { "page": 2, "type": "FIGURE", "location": { "l": 152.16, "t": 505.44, "r": 166.8, "b": 491.28 }, "text": "", "reading_order": 20 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 154, "t": 504.5514, "r": 166, "b": 492.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q2_title_change", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 21 }, { "page": 2, "type": "TEXT", "location": { "l": 74.4, "t": 483.84, "r": 174.24, "b": 472.8 }, "text": "If yes, indicate new title:", "reading_order": 22 }, { "page": 2, "type": "TEXT", "location": { "l": 222, "t": 505.44, "r": 254.88, "b": 491.76 }, "text": "6 No", "reading_order": 23 }, { "page": 2, "type": "FIGURE", "location": { "l": 222.48, "t": 505.2, "r": 237.36, "b": 491.52 }, "text": "", "reading_order": 24 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 224, "t": 504.5514, "r": 236, "b": 492.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q2_title_change", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 25 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 200, "t": 486.5514, "r": 564, "b": 471.5514 }, "text": "New title", "field_kind": "text", "label": "New title", "pdf_field_name": "q2_new_title", "pdf_field_type": "Text", "reading_order": 26 }, { "page": 2, "type": "TEXT", "location": { "l": 53.04, "t": 460.08, "r": 533.52, "b": 416.4 }, "text": "3 Is this a one-time request for a deviation from the currently approved protocol, or an exception to the currently approved enrollment criteria?\nYes No", "reading_order": 27 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 76, "t": 433.5514, "r": 88, "b": 421.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q3_deviation", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 28 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 146, "t": 433.5514, "r": 158, "b": 421.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q3_deviation", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 29 }, { "page": 2, "type": "FIGURE", "location": { "l": 51.84, "t": 412.56, "r": 67.2, "b": 397.68 }, "text": "", "reading_order": 30 }, { "page": 2, "type": "TITLE", "location": { "l": 51.36, "t": 411.6, "r": 222.96, "b": 398.64 }, "text": "4 Consent / Assent Form change?", "reading_order": 31, "level": 2 }, { "page": 2, "type": "FIGURE", "location": { "l": 241.68, "t": 413.76, "r": 278.88, "b": 399.36 }, "text": "", "reading_order": 32 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 243.692, "t": 412.5514, "r": 255.692, "b": 400.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q4_consent", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 33 }, { "page": 2, "type": "TEXT", "location": { "l": 311.76, "t": 413.76, "r": 344.16, "b": 399.6 }, "text": "6 No", "reading_order": 34 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 313.692, "t": 412.5514, "r": 325.692, "b": 400.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q4_consent", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 35 }, { "page": 2, "type": "TEXT", "location": { "l": 72.96, "t": 394.56, "r": 514.8, "b": 383.52 }, "text": "If yes, be sure changes are reflected in all revised consent/assent documents and any applicable HIPAA documents.", "reading_order": 36 }, { "page": 2, "type": "FIGURE", "location": { "l": 51.84, "t": 373.44, "r": 67.2, "b": 358.56 }, "text": "", "reading_order": 37 }, { "page": 2, "type": "TITLE", "location": { "l": 51.36, "t": 372.72, "r": 128.4, "b": 359.52 }, "text": "5 Check one:", "reading_order": 38, "level": 2 }, { "page": 2, "type": "TEXT", "location": { "l": 75.36, "t": 360, "r": 363.6, "b": 329.04 }, "text": "6 This modification does NOT increase risk to study participants.\n6 This modification may or will increase risk to study participants.", "reading_order": 39 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 80, "t": 359.5514, "r": 92, "b": 347.5514 }, "text": "no_increase", "field_kind": "radio", "label": "no_increase", "pdf_field_name": "q5_risk", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 40 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 80, "t": 342.5514, "r": 92, "b": 330.5514 }, "text": "no_increase", "field_kind": "radio", "label": "no_increase", "pdf_field_name": "q5_risk", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 41 }, { "page": 2, "type": "TEXT", "location": { "l": 50.88, "t": 316.56, "r": 438.48, "b": 288.48 }, "text": "6 Is this modification request due to an Unanticipated Problem or Adverse Event?\nYes No", "reading_order": 42 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 76, "t": 302.5514, "r": 88, "b": 290.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q6_unanticipated", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 43 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 146, "t": 302.5514, "r": 158, "b": 290.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q6_unanticipated", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 44 }, { "page": 2, "type": "TEXT", "location": { "l": 53.52, "t": 279.36, "r": 545.76, "b": 183.6 }, "text": "7 In your professional opinion, does this modification involve information that might relate to a subject's willingness to continue to take part in the research?\nYes No\nIf yes, state how the information will be communicated to subjects (i.e., re-consent, send letter, etc.):", "reading_order": 45 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 76, "t": 254.5514, "r": 88, "b": 242.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q7_willingness", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 46 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 146, "t": 254.5514, "r": 158, "b": 242.5514 }, "text": "Yes", "field_kind": "radio", "label": "Yes", "pdf_field_name": "q7_willingness", "pdf_field_type": "RadioButton", "value": "Off", "reading_order": 47 }, { "page": 2, "type": "FORM_FIELD", "location": { "l": 76, "t": 218.5514, "r": 564, "b": 182.5514 }, "text": "How communicated", "field_kind": "text", "label": "How communicated", "pdf_field_name": "q7_how", "pdf_field_type": "Text", "reading_order": 48 } ] }, { "page": 3, "items": [ { "page": 3, "type": "TITLE", "location": { "l": 223.92, "t": 687.12, "r": 388.08, "b": 672 }, "text": "Modification Request Form", "reading_order": 0, "level": 1 }, { "page": 3, "type": "TITLE", "location": { "l": 54.96, "t": 642.96, "r": 486.48, "b": 629.04 }, "text": "8. Changes Made To — check all that apply and attach appropriate documents", "reading_order": 1, "level": 2 }, { "page": 3, "type": "TITLE", "location": { "l": 43.68, "t": 622.8, "r": 216.96, "b": 611.04 }, "text": "Form A: General Information Sheet", "reading_order": 2, "level": 2 }, { "page": 3, "type": "TITLE", "location": { "l": 321.12, "t": 622.56, "r": 540.72, "b": 610.8 }, "text": "Form B: Research Description & Appendices", "reading_order": 3, "level": 2 }, { "page": 3, "type": "TEXT", "location": { "l": 42, "t": 604.32, "r": 184.08, "b": 591.12 }, "text": "Anticipated Project End Date", "reading_order": 4 }, { "page": 3, "type": "FORM_FIELD", "location": { "l": 44, "t": 603.5514, "r": 56, "b": 591.5514 }, "text": "a_end_date", "field_kind": "checkbox", "label": "a_end_date", "pdf_field_name": "a_end_date", "pdf_field_type": "CheckBox", "value": "Off", "reading_order": 5 }, { "page": 3, "type": "TEXT", "location": { "l": 42, "t": 585.84, "r": 163.2, "b": 571.68 }, "text": "□ Estimated # of Subjects", "reading_order": 6 }, { "page": 3, "type": "FORM_FIELD", "location": { "l": 44, "t": 584.5514, "r": 56, "b": 572.5514 }, "text": "a_num_subjects", "field_kind": "checkbox", "label": "a_num_subjects", "pdf_field_name": "a_num_subjects", "pdf_field_type": "CheckBox", "value": "Off", "reading_order": 7 }, { "page": 3, "type": "TEXT", "location": { "l": 319.92, "t": 604.32, "r": 384.48, "b": 590.88 }, "text": "□ Objectives", "reading_order": 8 }, { "page": 3, "type": "FORM_FIELD", "location": { "l": 321, "t": 603.5514, "r": 333, "b": 591.5514 }, "text": "b_objectives", "field_kind": "checkbox", "label": "b_objectives", "pdf_field_name": "b_objectives", "pdf_field_type": "CheckBox", "value": "Off", "reading_order": 9 }, { "page": 3, "type": "TEXT", "location": { "l": 319.2, "t": 585.36, "r": 456.72, "b": 571.68 }, "text": "Inclusion / Exclusion Criteria", "reading_order": 10 }, { "page": 3, "type": "FORM_FIELD", "location": { "l": 321, "t": 584.5514, "r": 333, "b": 572.5514 }, "text": "b_incl_excl", "field_kind": "checkbox", "label": "b_incl_excl", "pdf_field_name": "b_incl_excl", "pdf_field_type": "CheckBox", "value": "Off", "reading_order": 11 }, { "page": 3, "type": "TEXT", "location": { "l": 42.24, "t": 566.4, "r": 143.28, "b": 552.48 }, "text": "☐ Subject Population", "reading_order": 12 }, { "page": 3, "type": "FORM_FIELD", "location": { "l": 44, "t": 565.5514, "r": 56, "b": 553.5514 }, "text": "a_subject_pop", "field_kind": "checkbox", "label": "a_subject_pop", "pdf_field_name": "a_subject_pop", "pdf_field_type": "CheckBox", "value": "Off", "reading_order": 13 }, { "page": 3, "type": "TEXT", "location": { "l": 42, "t": 547.68, "r": 190.08, "b": 533.76 }, "text": "□ Vulnerable Subject Population", "reading_order": 14 }, { "page": 3, "type": "FORM_FIELD", "location": { "l": 44, "t": 546.5514, "r": 56, "b": 534.5514 }, "text": "a_vuln_pop", "field_kind": "checkbox", "label": "a_vuln_pop", "pdf_field_name": "a_vuln_pop", "pdf_field_type": 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