Syncop
Demo — not signed in Sign in 22
Demo data. This console is backed by an in-memory sample dataset. Signing here is a UI demonstration only — it is not a validated 21 CFR Part 11 electronic signature, and the audit chain it appends to is rebuilt from seed data on every restart.

Protocols

Protocol extraction

NCT02319837_EMBARK_protocol.pdf — STU-2026-200a

Extracted text
Waiting for review
Status
124 of 124
Pages read
50%
Confidence (review below 85%)
32
Entities flagged for review
Protocol number
STU-2026-200a
File
NCT02319837_EMBARK_protocol.pdf 0a687ca452002cf95a03289391413075022976423858a3d85597c76c842e222f
OCR
6 page(s) read by tesseract
Schedule of Activities
Pages [104, 105]
Draft
6 epochs, 12 visits, 25 activities, 64 conditional cells

Review

The draft's confidence is below the cutoff, so it waits for a reviewer. Check it against the protocol, correct what was read wrongly in the editor below, then approve it to record it as a study. The approval is recorded in the audit ledger under your name, with the time, its purpose and your corrections.

Sign in to correct or approve: corrections and approvals are recorded under the name of whoever makes them.

How the protocol was read

Extracted Schedule of Activities

Study design — Main Timeline. Highlighted visits and activities were read with less confidence than the cutoff: check them against the protocol.
Activity Day -4to-1 to na Screening Day -4 0..+3 d Day -1 |] Screening Day -1 60% Day 1 1 na S| Screening Day 1 48% et ta GO] tn tb wn Treatment 21% men am fo tt i Treatment 20% w Ble & lan mt OT CT Treatment 27% Day 37 253 15 CE Treatment Day 37 67% Day 41 281 45 Treatment Day 41 56% Day 49 [3] 337 15 Unsched Day 49 52% Varies na na Unsched [1] Varies na -3 to +10 Safety FU [2] Every 12 Every 84 +7 LTFU [3]
Informed consent, screen number [5] Medical history «| 43% X X[1] X[2] X[3]
Eligibility criteria [| 39% X[4] X[5] X[6] X[7]
12-Lead ECG (local read) 10% X[8] X[9] X[10]
Chest x-ray or CT scan 79% X
Abdominopelvic CT/MRI; bone scan 73% X X X X X
Randomization authorization form [9] 50% X X[11]
Randomization 33% X[12] X[13] X[14] X[15] X[16]
Vital signs (temperature, BP, heart rate) 79% X X X[17] X X X X X
Complete physical examination [11] 77% X X
Brief physical examination [12] 30% X[18] X[19] X[20] X[21] X[22]
ECOG performance status 44% X X[23] X[24]
Brief Pain Inventory (Short Form) [13] 39% X[25] X[26] X[27] X[28] X[29] X[30] X
FACT-P, EQ-5D-SL, QLQ-PR25 questionn aires [13] Symptomatic skeletal events [16] 33% X[31] X[32] X[33] X[34] X[35] X[36] X X[37]
Adverse events review 32% X X[38] X[39] X[40] X[41] X[42] X[43]
[17] 82% X[44]
Concomitant medications review 41% X X X[45] X[46] X[47]
Leuprolide injection 62% X X[48] X[49] X[50] X[51] X
[19] X[52] X[53]
Open-label enzalutamide dispensing [19] 69% X X[54] X[55] X[56] X[57]
Blinded study drug dispensing [19] 77% X X[58] X[59] X[60] X[61]
Study drug accountability 76% X[62] X X X X
Long-term follow-up assessments [22] 35% X[63] X[64] X
Serum chemistry, hematology 74% X X X X X X X
Testosterone 77% X X X X X X X
Prostate-specific antigen 77% X X X X X X X X
  1. [1] {|
  2. [2] |]
  3. [3] |]
  4. [4] Pa]
  5. [5] {|
  6. [6] ~~]
  7. [7] [|
  8. [8] Pa
  9. [9] ttt
  10. [10] rt
  11. [11] [|
  12. [12] CU}
  13. [13] XT
  14. [14] UT
  15. [15] CUT
  16. [16] CCT
  17. [17] |X|
  18. [18] ~ i=)
  19. [19] op]
  20. [20] OM
  21. [21] os]
  22. [22] os]
  23. [23] a
  24. [24] MM]
  25. [25] vad [14]
  26. [26] mst
  27. [27] mM]
  28. [28] oes]
  29. [29] oes]
  30. [30] a
  31. [31] res
  32. [32] ret as
  33. [33] rm] a
  34. [34] ra] ~
  35. [35] ra] ~
  36. [36] va
  37. [37] X[is] a
  38. [38] 4
  39. [39] ca
  40. [40] ast
  41. [41] LE
  42. [42] ee
  43. [43] TE
  44. [44] [18]
  45. [45] cast
  46. [46] ast
  47. [47] |=]
  48. [48] cat
  49. [49] at
  50. [50] VPS
  51. [51] VPS
  52. [52] A 20
  53. [53] A 20
  54. [54] |x|x
  55. [55] VPS A [20]
  56. [56] VPS A [20]
  57. [57] X[21]
  58. [58] |x|xX
  59. [59] VPS A [20]
  60. [60] VPS A [20]
  61. [61] X[21]
  62. [62] X|
  63. [63] Ti
  64. [64] Pt