A Screen patients G Review/Accountability/Sign off Form 2:Dosing Log M IMP Supply/Management. SAE clinical review/causality Assessment and Sign off

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1 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of Legend Use this legend to complete the Duties column. For each individual listed in the Name column, enter the letter(s) (e.g. a, c, e) from the legend below that correspond to their trial-related duties. If there are significant protocol related duties that are not already included in the legend, add them in the empty spaces provided below. Refer to reverse for further guidance. Neonatal Staff Pharmacy Staff A Screen patients G Review/Accountability/Sign off Form 2:Dosing Log M IMP Supply/Management B Assessment of eligibility H SAE clinical review/causality Assessment and Sign off N Completion of Stock Balance Log C Obtain Informed Consent I O D Randomisation J P E Prescribe Investigational Medicinal product (IMP) K Q F Provision of local ELFIN training L R The Investigator should sign below during the Site Close-Out Visit. I have reviewed the information on this log and have found it to be accurate. All delegated duties were performed with my authorisation. Investigator : Site Close-Out Visit Date: ELFIN Site Delegation Log Version 2 18/9/2015

2 Guidelines on ELFIN Training and Delegation (Review in conjunction with Trust policy) The ELFIN trial is being carried out in large neonatal units and involves potentially many staff providing care for trial participants. It is recognised that the provision of GCP training to all staff may not be feasible, leading to these guidelines. A tiered system is outlined in which GCP-trained doctors and nurses disseminate training, including the practical application of GCP principles as these apply to study-specific tasks. These tasks are frequently aspects of standard care (such as giving an oral medicine) that have been adapted to form part of the trial protocol. The diagram below is indicative of the pragmatic approach proposed to ensure all staff are appropriately supervised, trained and delegated for the tasks or duties that they perform when taking part in ELFIN. Investigator Local Research Nurse With responsibility for training Specific guidelines on delegation and training at recruiting sites are as follows: GCP training for the Investigator (PI) and Local Research Nurse (LRN) is mandatory. It is expected that GCP training be maintained in line with the policy of the participating Trust. Responsibility for disseminating training should be delegated by the PI to the LRN (or other appropriate team member) once they are satisfied that they can deliver the training effectively. It is expected that trainers be GCP-trained where they are training other staff expected to have GCP to perform that task. The initial delegation log returned to the ELFIN Coordinating Centre must include at minimum the Local Research Nurse (LRN), a person delegated responsibility for training locally (if not the LRN or Investigator) and a pharmacist or pharmacy technician with responsibility for managing the stock of IMP in the pharmacy. Staff taking consent must be trained in GCP and have received ELFIN study-specific training in consent evidenced on the ELFIN Training Log. CVs and GCP certificates to staff taking consent should be sent to the coordinating centre when they are added to the delegation log. Non-GCP trained Nurses Prepare and administer IMP Other GCP trained staff Non-GCP trained Doctors Prescribing of IMP Training packages are provided to support recruiting and continuing care site staff to understand the background and tasks involved in the ELFIN trial. The packages are designed to encourage a uniformity in the training provision across the sites in this multi-centre trial. The ELFIN Training Log will indicate the training packages required, depending on the level of involvement of each staff group. Staff prescribing ELFIN investigational medicinal product must have received study-specific training in prescribing, evidenced on the ELFIN Training Log, prior to prescribing IMP. They should be listed on the delegation log as prescribers, but may not necessarily have GCP training (e.g. junior medical staff). It is expected that a potentially large number of nurses will be involved in the preparation and administration of ELFIN investigational medicinal product (IMP). These nurses are not expected to be GCP trained and need not be listed on the delegation log. However they must have received study-specific training evidenced on the ELFIN Training Log prior to preparing or administering IMP. (Guidelines on ELFIN Training and Delegation Version 1 10/09/2015)

3 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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5 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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7 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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9 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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11 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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13 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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15 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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17 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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19 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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21 Site Delegation Log Study Name: Hospital: ELFIN EudraCT No: REC Reference: 13/EM/0118 Title: Investigator: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants Page: of This log should include all relevant trial staff and other clinical staff who routinely carry out trial procedures or who have specific data collection/interpretation duties. Add new or replacement staff as appropriate. Please send updated copies to the ELFIN Co-ordinating Centre. Note: Please complete the log and obtain the PI s approval before starting trial duties. Delegated Individual investigator Full Name (Please print) Role Duties (Use codes listed page 1) From Date of duties End address Usual Initials PI s Date ELFIN Site Delegation Log Version 2 18/9/2015

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