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Completing ACST-2 Forms

Completing ACST-2 Forms. ACST-2 Study Forms . ACST-2 Study Forms . Please keep a copy of the Consent, Randomisation & One Month Follow-up Forms in the hospital notes/patient files

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Completing ACST-2 Forms

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  1. Completing ACST-2 Forms

  2. ACST-2 Study Forms

  3. ACST-2 Study Forms • Please keep a copy of the Consent, Randomisation & One Month Follow-up Forms in the hospital notes/patient files • Post the originals to the ACST-2 office in reply paid envelopes or fax a copy (+44 (0) 1865 221 027 or send a scanned copy via email (removing any names of patients)

  4. Questions- Consent & Randomisation Forms • Consent needs to be signed by patient and the doctor on the same day. • Complete part 2 of the randomisation form either online or send paper form to us

  5. Questions -One month follow up form Section B The duplex Doppler must be done Left and Right sides. Section E Don’t forget to complete the date for Current Status. Current therapy please be sure to select Yes or No to each box – do not use crosses or ticks or leave blank. Only complete page two of the One Month Follow-up Form if there is a major event.

  6. Common Queries • The patient cannot have the procedure due to a medical reason. Please record why on the one month follow up form on Page 2 under ‘Any additional comments or information (as narrative)? If the patient does end up having the procedure later at anytime (even years later), please complete a new One month Follow up Form with all the procedural details and send this to the ACST-2 office.

  7. Common Queries • The patient withdraws from the procedure but not from the trial Please record this on the one month follow up form on Page 2 under ‘Any additional comments or information (as narrative)? Valuable information is provided even though the patient did not have the procedure.

  8. Common Queries • A patient has a crossover due to a medical reason Please record why on the one month follow up form to note this on Page 2 under ‘Any additional comments or information (as narrative)? Then complete the rest of the form as per normal.

  9. What are Major Events • Stroke • MI • Death We need information about these events, and willask for: • Stroke: CT , initial and 6 month modified Rankin scores • MI: ECGs, Cardiac markers • Deaths: Death certificate if available Please report such events to acst@nds.ox.ac.uk as soon as possible (ideally within 1 week)

  10. We are here to help • If you have any questions please feel free to email acst@nds.ox.ac.uk or call +44 (0) 1865 223 078

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