MAPS-2 - recent changes

Date	CRF / version	Details of changes
25 May 2022	Randomisation v1.1	B6: Updated the definition of Definite or probable pneumonia.
	Day 14 follow-up v2.0	Added section G: Coenrolment. Added question: C9: Please list any non-serious adverse event that happened from day participant randomised until day 14. Numbering: B4b corrected to B5b. Numbering: B5 corrected to B6.
1 Jul 2022	Randomisation v1.2	B5: Added NIHSS ≥ 6 AND prior to existing text for Dysphagia... Added text: To be eligible, Inclusion criteria B1-B3 must be YES and either B4 or B5 must be YES.
2 Aug 2022	Day 14 follow-up v2.1	Amended title from Trial Day 14 follow-up to Trial Day 14 or Discharge Day assessment. Added A4: Participant status. Added option to E1: mRS, 6- Died.
10 Aug 2022	Randomisation v1.3	Changed B10: eGFR < 30 ml/hour to eGFR < 30 ml/min.
14 Nov 2022	Randomisation v1.4	Changed B16: Removed duplicate has from Has appropriate consent been obtained? Changed F1: Weight (kg) changed label Permitted range 40-200 kg to Permitted range 35-200 kg. Added F4a: Associate PI involved? Added F4b: Name of associate PI. Added Comments.
	Daily clinical monitoring log v1.1	Added A3: Participant status. Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
	Results of cultures v1.1	Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
	Antibiotic treatment v1.1	Added B5a: Antibiotic status. Added B5b: End date. Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
	Site-to-site transfer v1.1	Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
	Discharge to the community v1.1	Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
	Vital status v1.1	Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
	Serious Adverse Event v1.1	B6a. Event diagnosis, correct typing mistake.
	Pneumonia diagnosis v1.1	Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
	Day 14 follow-up v2.2	Changed A3: Participant status, added Palliative care. Added D1: Was NIHSS performed within +/- 3 days of day-14 or date of discharge to the community? Added D1a: If NIHSS not performed, please specify reason why. Added D1b: If NIHSS performed prior to day-14/day of discharge, enter date. Added D1c: If full NIHSS break down is not available please give total NIHSS here. Added D13: NIHSS total. Added F1: Was DSRS performed on day-14 or day of discharge? Added F1a: If DSRS not performed, please specify reason why. Added F5: DSRS total Added G1: Was EuroQol 5D-5L performed on day-14 or day of discharge? Added G1a: If EQ-5D-5L not performed, please specify reason why Added G7: EQ-5D-5L total. Added J1. Diagnosis of pneumonia made at any time during day 1-14. Added J1a: If changed, please give details. Added Are any values missing due to tests not done (or measures not taken). Added Comments and full explanation for missing data.
10 Mar 2023	Randomisation v1.5	Changed B3: Onset from 9 hours to 24 hours.
19 Jun 2023	Protocol violation v1.1	Changed B2: Type of protocol violation Changed option 2: Randomisation > 25 hours symptom onset to Randomisation > 25 hours symptom onset Changed option 4: Patient randomised with NIHSS >6, but < 10, without dysphagia to Patient randomised with NIHSS >6, but no dysphagia.
12 Jul 2023	Serious Adverse Event v1.2	Added DO NOT LOCK THE RECORD UNTIL IT HAS BEEN REVIEWED to pending review warning. Added DO NOT LOCK THE RECORD UNTIL IT HAS BEEN UPDATED & REVIEWED to insufficient information warning. Added DO NOT LOCK THE RECORD UNTIL IT HAS BEEN UPDATED & REVIEWED before locking record. B15. Please classify the event, amend options. G3. SAE classification by reviewer, amend options. Section G: CI review, amend label.
3 May 2024	Protocol violation v1.2	Changed B2: Type of protocol violation Changed B2: option 12: Patient randomised whilst co-enrolled in CTIMP without sponsor agreement Added B2: option 19: Incorrect route of trial treatment administration .
	Day 14 follow-up v2.3	Added B7a: Did the participant receive any other antiemetics during the trial period? Added B7b: If yes, how many times did the participant receive any other antiemetics during the trial period?. Added B7c: If yes, which antiemetic did the participant receive during the trial period?.
	Daily clinical monitoring log v1.2	Added Day number (1-14) and additional dosage.
4 Jun 2024	Serious Adverse Event v1.3	Change Appendix 2 to read Appendix 3 On the printed CRF, add Appendix 3
18 Jun 2024	Serious Adverse Event v1.4	Add section G: PI Review Add G1. Reviewed by PI Add G2. I have reviewed and agree with this SAE Add G3. Please enter PI name Add G4. Please sign the form
8 Jan 2025	Randomisation v1.6	Changed F1: Weight (kg) changed hint Permitted range 35-200 kg to Permitted range 35.00-200.00 kg - please note format: 2 decimal places only. Added Protocol version
	Daily clinical monitoring log v1.3	Changed A3a: Participant status changed label If deceased or withdrawn complete the "Vital status check/notification of death/withdrawal" CRF. to If deceased complete the "Notification of death" CRF. If withdrawn complete the "Withdrawal" CRF.
	Vital status v1.2	Changed heading Vital status check/notification of death/withdrawal v1.1 to Notification of death v1.2 Changed B1: Vital status removed option to select status and default to death automatically
	Serious Adverse Event v1.5	Changed heading Serious Adverse Event v1.4 to Serious Adverse Event or Event of Special Interest v1.5 Added unique Event number Changed APPENDIX 3: Expected Stroke Symptoms and Complications Changed Time reported after awareness changed label The SAE must be reported to An SAE must be reported Changed B6a: Event diagnosis changed label Please select the sub-categories of the event to Please select the categories of the event. Changed B15: Please classify the event added option EoSI Changed G2: I have reviewed and agree with this SAE to I have reviewed and agree with this classification
	Withdrawal notification v1.1	Changed B1: Vital status removed option to select status and default to withdraw automatically
	Month 6 follow-up v1.4	Changed A3a: Participant status changed label If deceased or withdrawn complete the "Vital status check/notification of death/withdrawal" CRF. to If deceased complete the "Notification of death" CRF. If withdrawn complete the "Withdrawal" CRF.
	Day 14 follow-up v2.4	Changed A3a: Participant status changed label If deceased or withdrawn complete the "Vital status check/notification of death/withdrawal" CRF. to If deceased complete the "Notification of death" CRF. If withdrawn complete the "Withdrawal" CRF. Changed C1a: A further stroke changed hint If yes, please complete SAE to If yes, please complted SAE/ EoSI form and categorise as EoSI Changed C2a: A collapse or cardiac/ respiratory arrest requiring resuscitation changed hint If yes, please complete SAE to If yes, please complted SAE/ EoSI form and categorise as EoSI Changed C4a: Definite epileptic seizure (focal or generalised) changed hint If yes, please complete SAE to If yes, please complted SAE/ EoSI form and categorise as EoSI Changed C5a: Orofacial dyskinesia changed hint If yes, please complete SAE to If yes, please complted SAE/ EoSI form and categorise as EoSI Changed C6a: Tardive dyskinesia changed hint If yes, please complete SAE to If yes, please complted SAE/ EoSI form and categorise as EoSI Changed C7a: A NEW diagnosis of Parkinson's disease changed hint If yes, please complete SAE to If yes, please complted SAE/ EoSI form and categorise as EoSI Changed C8: Any serious adverse event changed label Any serious adverse event that is NOT a known complication of stroke. to Any serious adverse event that is NOT a known complication of stroke or known side effect of Metoclopramide. Changed note post C9: If there have been any SAEs, please complete the SAE report form changed warning Remember that complications of the stroke as per appendix 3 should not be reporeted as SAEs to Remember that complications of the stroke (Appendix 3) and known side effects of Metoclopramide (Appendix 1) should not be reported as SAEs
17 Jun 2025	Serious Adverse Event v1.6	Added Specific safety endpoints - Events referred to as Events of Special Interest (EoSI) Added F2. Name of person completing the form Added F3. Email of person completing the form Added F4. Username of person completing the form Added G2b. PI Comments Added G5. Email of PI Added Section H: CI review Added H6. Event report Concluded or Opened Added Section I: PI acknowledgement of CI review Added Section J: Verification and/or Adjudication review Added Section K: Trial manager review Added Section L: Messages, notes and queries
21 Jul 2025	Serious Adverse Event v1.7	Added G5a. By clicking this you are e-signing this review
	Withdrawal notification v1.2	Changed C1. Username of person completing the form Added C2a. Full name of person completing the form Changed C2b. I confirm that the contents of this form are accurate and complete
	Randomisation v1.7	A4. Date of birth will not be available one day after randomisation. Added G1. Name of person completing the form Added G2. Email of person completing the form Added G3. Username of person completing the form Added G4. Please enter PI name Added G5. Email of PI