THE ADEPT STUDY Data Collection: Getting it Right!

Consent Form: The most important document of all. This MUST be completed and signed by the parent(s) of the infant BEFORE any data is collected.

Golden Rules For Completing Data Forms: PLEASE Write CLEARLY PLEASE Answer ALL the questions PLEASE Always complete the baby’s details, otherwise we have no way of matching the forms to the baby If there is anything you are unsure about please ring the Co-ordinating Centre, that’s what we’re there for. Following these simple rules means that once you have completed the forms for a baby you will never have to deal with these forms again. It also means when we receive the forms, we can enter the data and file it away.

ADEPT Data Forms: Entry Form Daily Feed Log Episodes of NEC or other Abdominal Pathology Form Serious adverse event (SAE)/suspected unexpected serious adverse reaction (SUSAR) Form 36 Week Form Discharge or Transfer Form

Entry Form: Page 1

Entry Form: Page 2

Entry Form: Page 3

Daily Feed Log: Page 1

Daily Feed Log: Page 2 & 3

Daily Feed Log: Page 4

Episodes of NEC or other Abdominal Pathology Form: Page 1

Episodes of NEC or other Abdominal Pathology Form: Page 2

Serious adverse event (SAE)/ suspected unexpected serious adverse reaction (SUSAR) Form

ADEPT Study Standard Operating Procedures (SOPs) for SAE/SUSARS

36 Week Form:

Discharge or Transfer Form: Page 1

Discharge or Transfer Form: Page 2

Discharge or Transfer Form: Page 3

Discharge or Transfer Form: Page 4

Please remember the Golden Rules : PLEASE Write CLEARLY PLEASE Answer ALL the questions PLEASE Always complete the baby’s details, otherwise we have no way of matching the forms to the baby Once you have completed any data form, please return it to the Co-ordinating Centre as soon as possible. THANK YOU