{ "document_id": 14851, "filename": "IRB_Modification_Form.pdf", "engine": "paddleocr_vl", "source_run_id": 14962, "generated_at": "2026-11-04T07:08:03+00:00", "page_count": 4, "counts_by_type": { "figure": 2, "footer": 8, "form_field": 53, "header": 7, "heading": 23, "link": 13, "list": 6, "list_item": 17, "table": 1, "table_cell": 2, "text": 35, "title": 1 }, "timings": { "total_ms": 534, "structure_ms": 426, "text_layer_ms": 14, "build_ms": 13 }, "pages": [ { "document_id": 14851, "page": 1, "width": 612, "height": 792, "rotation": 0, "pipeline_version": "paddleocr-vl-1.6+paul-48", "width_pt": 612, "height_pt": 792, "engine": "paddleocr_vl", "source_run_id": 14962, "item_count": 30, "counts_by_type": { "footer": 2, "form_field": 2, "header": 2, "heading": 5, "link": 4, "table": 1, "table_cell": 2, "text": 12 }, "build_ms": 3, "items": [ { "id": "p1.1", "order": 1, "type": "header", "bbox": { "l": 170.88, "t": 735.84, "r": 427.68, "b": 677.04 }, "text": "Kentucky State University\nOffice of Research and Innovation\n400 E Main St, Frankfort KY, 40601\nORI@KYSU.EDU (502) 597-5997", "attrs": { "block_label": "header" }, "level": 2, "reading_order": 0 }, { "id": "p1.2", "order": 2, "type": "header", "bbox": { "l": 149.76, "t": 666.48, "r": 461.52, "b": 634.56 }, "text": "Modification Request Form\nKentucky State University • Institutional Review Board (IRB)", "attrs": { "block_label": "header" }, "children": [ { "id": "p1.2.1", "order": 3, "type": "link", "bbox": { "l": 299.4008, "t": 648.8812, "r": 459.2527, "b": 635.3812 }, "text": "Institutional Review Board (IRB)", "attrs": { "uri": "https://www.kysu.edu/academics/research-and-innovation/irb", "action_type": "/URI" }, "reading_order": 0 } ], "level": 2, "reading_order": 1 }, { "id": "p1.3", "order": 4, "type": "table", "bbox": { "l": 37.44, "t": 625.68, "r": 570.96, "b": 605.28 }, "text": "", "attrs": { "block_label": "table", "n_rows": 1, "n_cols": 2, "integrity": { "cells_checked": 1, "cells_flagged": 0 } }, "children": [ { "id": "p1.3.1", "order": 5, "type": "table_cell", "bbox": { "l": 42, "t": 617.2022, "r": 82.6505, "b": 608.4147 }, "text": "PI Name:", "attrs": { "row": 0, "col": 0, "rowspan": 1, "colspan": 1, "bbox_refit": true, "column_header": true, "header_source": "pdf" }, "children": [ { "id": "p1.3.1.1", "order": 6, "type": "form_field", "bbox": { "l": 94, "t": 622.3812, "r": 304, "b": 606.3812 }, "text": "", "attrs": { "field_kind": "text", "label": "Principal Investigator name", "pdf_field_name": "pi_name", "source": "acroform", "row": 0, "col": 0, "rowspan": 1, "colspan": 1, "text_offset": 8, "text_span": 0 }, "reading_order": 0 } ], "reading_order": 0 }, { "id": "p1.3.2", "order": 7, "type": "table_cell", "bbox": { "l": 304.2, "t": 625.68, "r": 570.96, "b": 605.28 }, "text": "", "attrs": { "row": 0, "col": 1, "rowspan": 1, "colspan": 1, "column_header": true, "header_source": "pdf" }, "reading_order": 1 } ], "reading_order": 2 }, { "id": "p1.4", "order": 8, "type": "heading", "bbox": { "l": 340.08, "t": 621.36, "r": 569.28, "b": 606.48 }, "text": "IRB #:", "children": [ { "id": "p1.4.1", "order": 9, "type": "form_field", "bbox": { "l": 380, "t": 622.3812, "r": 570, "b": 606.3812 }, "text": "", "attrs": { "field_kind": "text", "label": "IRB #:", "pdf_field_name": "irb_number", "source": "acroform", "label_source": "parent_text", "label_ref": "p1.5", "text_offset": 6, "text_span": 0 }, "reading_order": 0 } ], "level": 3, "reading_order": 3 }, { "id": "p1.5", "order": 10, "type": "heading", "bbox": { "l": 340.56, "t": 619.44, "r": 371.28, "b": 607.92 }, "text": "IRB #:", "level": 3, "reading_order": 4 }, { "id": "p1.6", "order": 11, "type": "heading", "bbox": { "l": 56.16, "t": 577.2, "r": 122.64, "b": 564 }, "text": "Instructions", "attrs": { "block_label": "paragraph_title" }, "level": 3, "reading_order": 5 }, { "id": "p1.7", "order": 12, "type": "text", "bbox": { "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": 6 }, { "id": "p1.8", "order": 13, "type": "text", "bbox": { "l": 56.16, "t": 536.4, "r": 316.08, "b": 524.88 }, "text": "Proposed changes to your current IRB-approved protocol.", "reading_order": 7 }, { "id": "p1.9", "order": 14, "type": "text", "bbox": { "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": 8 }, { "id": "p1.10", "order": 15, "type": "heading", "bbox": { "l": 56.16, "t": 489.36, "r": 160.56, "b": 477.84 }, "text": "Do NOT use this form:", "attrs": { "block_label": "paragraph_title" }, "level": 3, "reading_order": 9 }, { "id": "p1.11", "order": 16, "type": "text", "bbox": { "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": 10 }, { "id": "p1.12", "order": 17, "type": "text", "bbox": { "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": 11 }, { "id": "p1.13", "order": 18, "type": "text", "bbox": { "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": 12 }, { "id": "p1.14", "order": 19, "type": "heading", "bbox": { "l": 55.68, "t": 400.8, "r": 146.16, "b": 389.52 }, "text": "Please be sure to...", "attrs": { "block_label": "paragraph_title" }, "level": 3, "reading_order": 13 }, { "id": "p1.15", "order": 20, "type": "text", "bbox": { "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.", "reading_order": 14 }, { "id": "p1.16", "order": 21, "type": "text", "bbox": { "l": 57.84, "t": 372.96, "r": 241.68, "b": 361.44 }, "text": "Complete and attach appropriate forms.", "reading_order": 15 }, { "id": "p1.17", "order": 22, "type": "text", "bbox": { "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.", "reading_order": 16 }, { "id": "p1.18", "order": 23, "type": "text", "bbox": { "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).", "reading_order": 17 }, { "id": "p1.19", "order": 24, "type": "text", "bbox": { "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.", "reading_order": 18 }, { "id": "p1.20", "order": 25, "type": "text", "bbox": { "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.", "reading_order": 19 }, { "id": "p1.21", "order": 26, "type": "footer", "bbox": { "l": 40.56, "t": 43.44, "r": 285.36, "b": 33.36 }, "text": "Research & Innovation (ORI) · IRB Guidelines · ORI@kysu.edu", "attrs": { "block_label": "footer" }, "children": [ { "id": "p1.21.1", "order": 27, "type": "link", "bbox": { "l": 42, "t": 44, "r": 144.704, "b": 33 }, "text": "Research & Innovation (ORI)", "attrs": { "uri": "https://www.kysu.edu/academics/research-and-innovation", "action_type": "/URI" }, "reading_order": 0 }, { "id": "p1.21.2", "order": 28, "type": "link", "bbox": { "l": 160.848, "t": 44, "r": 214.2, "b": 33 }, "text": "IRB Guidelines", "attrs": { "uri": "https://www.kysu.edu/academics/research-and-innovation/irb", "action_type": "/URI" }, "reading_order": 1 }, { "id": "p1.21.3", "order": 29, "type": "link", "bbox": { "l": 230.344, "t": 44, "r": 284.704, "b": 33 }, "text": "ORI@kysu.edu", "attrs": { "uri": "mailto:ORI@kysu.edu", "action_type": "/URI" }, "reading_order": 2 } ], "reading_order": 20 }, { "id": "p1.22", "order": 30, "type": "footer", "bbox": { "l": 528, "t": 43.2, "r": 570.96, "b": 33.36 }, "text": "Page 1 of 4", "attrs": { "block_label": "number" }, "reading_order": 21 } ] }, { "document_id": 14851, "page": 2, "width": 612, "height": 792, "rotation": 0, "pipeline_version": "paddleocr-vl-1.6+paul-48", "width_pt": 612, "height_pt": 792, "engine": "paddleocr_vl", "source_run_id": 14962, "item_count": 58, "counts_by_type": { "figure": 2, "footer": 2, "form_field": 23, "header": 2, "heading": 6, "link": 3, "list": 2, "list_item": 6, "text": 12 }, "build_ms": 6, "items": [ { "id": "p2.1", "order": 1, "type": "header", "bbox": { "l": 207.6, "t": 741.12, "r": 393.84, "b": 697.68 }, "text": "Kentucky State University\nOffice of Research and Innovation\n400 E Main St, Frankfort KY, 40601\nORI@KYSU.EDU (502) 597-5997", "attrs": { "block_label": "header" }, "level": 2, "reading_order": 0 }, { "id": "p2.2", "order": 2, "type": "header", "bbox": { "l": 224.16, "t": 687.12, "r": 388.08, "b": 672.24 }, "text": "Modification Request Form", "attrs": { "block_label": "header" }, "level": 2, "reading_order": 1 }, { "id": "p2.3", "order": 3, "type": "heading", "bbox": { "l": 40.8, "t": 656.64, "r": 98.88, "b": 644.64 }, "text": "PI Signature", "attrs": { "block_label": "paragraph_title" }, "children": [ { "id": "p2.3.1", "order": 4, "type": "form_field", "bbox": { "l": 42, "t": 639.5514, "r": 354, "b": 609.5514 }, "text": "", "attrs": { "field_kind": "text", "label": "PI Signature", "pdf_field_name": "pi_signature", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.4" }, "reading_order": 0 } ], "level": 3, "reading_order": 2 }, { "id": "p2.4", "order": 5, "type": "text", "bbox": { "l": 39.36, "t": 655.92, "r": 394.08, "b": 644.16 }, "text": "The quick brown fox jumps over the lazy dog.", "reading_order": 3 }, { "id": "p2.5", "order": 6, "type": "text", "bbox": { "l": 372.96, "t": 655.92, "r": 396, "b": 645.36 }, "text": "Date", "children": [ { "id": "p2.5.1", "order": 7, "type": "form_field", "bbox": { "l": 374, "t": 639.5514, "r": 570, "b": 609.5514 }, "text": "", "attrs": { "field_kind": "text", "label": "Date", "pdf_field_name": "sig_date", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.6" }, "reading_order": 0 } ], "reading_order": 4 }, { "id": "p2.6", "order": 8, "type": "figure", "bbox": { "l": 88.5816, "t": 650.617, "r": 212.0726, "b": 604.802 }, "text": "", "attrs": { "source": "pdf_image" }, "reading_order": 5 }, { "id": "p2.7", "order": 9, "type": "heading", "bbox": { "l": 56.16, "t": 587.28, "r": 163.68, "b": 574.08 }, "text": "Modification Details", "attrs": { "block_label": "paragraph_title" }, "level": 3, "reading_order": 6 }, { "id": "p2.8", "order": 10, "type": "heading", "bbox": { "l": 52.08, "t": 564.72, "r": 290.16, "b": 552.24 }, "text": "1 Address change for protocol correspondence?", "attrs": { "block_label": "paragraph_title" }, "children": [ { "id": "p2.8.1", "order": 11, "type": "form_field", "bbox": { "l": 52.8, "t": 565.92, "r": 66.72, "b": 550.8 }, "text": "", "attrs": { "field_kind": "checkbox", "label": "Address change for protocol correspondence?", "source": "tiny_figure", "label_source": "parent_text", "label_ref": "p2.9", "text_offset": 2, "text_span": 0 }, "reading_order": 0 } ], "level": 3, "reading_order": 7 }, { "id": "p2.9", "order": 12, "type": "text", "bbox": { "l": 74.64, "t": 547.92, "r": 192, "b": 536.88 }, "text": "If yes, indicate new address:", "children": [ { "id": "p2.9.1", "order": 13, "type": "form_field", "bbox": { "l": 204, "t": 550.5514, "r": 564, "b": 535.5514 }, "text": "", "attrs": { "field_kind": "text", "label": "New address", "pdf_field_name": "q1_new_address", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.10", "text_offset": 29, "text_span": 0 }, "reading_order": 0 } ], "reading_order": 8 }, { "id": "p2.10", "order": 14, "type": "text", "bbox": { "l": 325.68, "t": 565.2, "r": 345.36, "b": 554.16 }, "text": "Yes", "children": [ { "id": "p2.10.1", "order": 15, "type": "form_field", "bbox": { "l": 243.692, "t": 412.5514, "r": 255.692, "b": 400.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q4_consent", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.11" }, "reading_order": 0 }, { "id": "p2.10.2", "order": 16, "type": "form_field", "bbox": { "l": 313.692, "t": 412.5514, "r": 325.692, "b": 400.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q4_consent", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.11" }, "reading_order": 1 }, { "id": "p2.10.3", "order": 17, "type": "form_field", "bbox": { "l": 76, "t": 302.5514, "r": 88, "b": 290.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q6_unanticipated", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.11" }, "reading_order": 2 }, { "id": "p2.10.4", "order": 18, "type": "form_field", "bbox": { "l": 310.211, "t": 566.5514, "r": 322.211, "b": 554.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q1_address", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.11", "text_offset": 0, "text_span": 0 }, "reading_order": 3 }, { "id": "p2.10.5", "order": 19, "type": "form_field", "bbox": { "l": 380.211, "t": 566.5514, "r": 392.211, "b": 554.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q1_address", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.11", "text_offset": 3, "text_span": 0 }, "reading_order": 4 }, { "id": "p2.10.6", "order": 20, "type": "form_field", "bbox": { "l": 154, "t": 504.5514, "r": 166, "b": 492.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q2_title_change", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.11" }, "reading_order": 5 }, { "id": "p2.10.7", "order": 21, "type": "form_field", "bbox": { "l": 224, "t": 504.5514, "r": 236, "b": 492.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q2_title_change", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.11" }, "reading_order": 6 } ], "reading_order": 9 }, { "id": "p2.11", "order": 22, "type": "text", "bbox": { "l": 378.96, "t": 567.12, "r": 410.88, "b": 553.68 }, "text": "6 No", "reading_order": 10 }, { "id": "p2.12", "order": 23, "type": "heading", "bbox": { "l": 50.88, "t": 524.16, "r": 130.32, "b": 509.76 }, "text": "2 Study Title:", "attrs": { "block_label": "paragraph_title" }, "children": [ { "id": "p2.12.1", "order": 24, "type": "form_field", "bbox": { "l": 137.7275, "t": 524.5514, "r": 564, "b": 509.5514 }, "text": "", "attrs": { "field_kind": "text", "label": "Study title", "pdf_field_name": "study_title", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.13", "text_offset": 14, "text_span": 0 }, "reading_order": 0 } ], "level": 3, "reading_order": 11 }, { "id": "p2.13", "order": 25, "type": "list", "bbox": { "l": 74.64, "t": 501.372, "r": 253.141, "b": 491.04 }, "text": "", "attrs": { "item_count": 2 }, "children": [ { "id": "p2.13.1", "order": 26, "type": "list_item", "bbox": { "l": 76, "t": 501.372, "r": 253.141, "b": 491.5845 }, "text": "Title change?", "reading_order": 0 }, { "id": "p2.13.2", "order": 27, "type": "list_item", "bbox": { "l": 74.64, "t": 496.8, "r": 134.88, "b": 491.04 }, "text": "6 Yes", "attrs": { "bbox_estimated": true }, "reading_order": 1 } ], "reading_order": 12 }, { "id": "p2.14", "order": 28, "type": "text", "bbox": { "l": 152.16, "t": 505.44, "r": 189.36, "b": 491.52 }, "text": "6 Yes", "reading_order": 13 }, { "id": "p2.15", "order": 29, "type": "text", "bbox": { "l": 74.4, "t": 483.84, "r": 174.24, "b": 472.8 }, "text": "If yes, indicate new title:", "children": [ { "id": "p2.15.1", "order": 30, "type": "form_field", "bbox": { "l": 200, "t": 486.5514, "r": 564, "b": 471.5514 }, "text": "", "attrs": { "field_kind": "text", "label": "New title", "pdf_field_name": "q2_new_title", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.16", "text_offset": 27, "text_span": 0 }, "reading_order": 0 } ], "reading_order": 14 }, { "id": "p2.16", "order": 31, "type": "text", "bbox": { "l": 222, "t": 505.44, "r": 254.88, "b": 491.76 }, "text": "6 No", "reading_order": 15 }, { "id": "p2.17", "order": 32, "type": "text", "bbox": { "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", "children": [ { "id": "p2.17.1", "order": 33, "type": "form_field", "bbox": { "l": 76, "t": 433.5514, "r": 88, "b": 421.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q3_deviation", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.18", "text_offset": 146, "text_span": 0 }, "reading_order": 0 }, { "id": "p2.17.2", "order": 34, "type": "form_field", "bbox": { "l": 146, "t": 433.5514, "r": 158, "b": 421.5514 }, "text": "Off", "attrs": { "field_kind": "radio", "label": "Yes", "pdf_field_name": "q3_deviation", "source": "acroform", "label_source": "parent_text", "label_ref": "p2.18", "text_offset": 149, "text_span": 0 }, "reading_order": 1 } ], "reading_order": 16 }, { "id": "p2.18", "order": 35, "type": "heading", "bbox": { "l": 51.36, "t": 411.6, "r": 222.96, "b": 398.64 }, "text": "4 Consent / Assent Form change?", "attrs": { "block_label": "paragraph_title" }, "children": [ { "id": "p2.18.1", "order": 36, "type": "form_field", "bbox": { "l": 51.84, "t": 412.56, "r": 67.2, "b": 397.68 }, "text": "", "attrs": { "field_kind": "checkbox", "label": "Consent / Assent 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