I2S2 TRAINING Good Clinical Practice tips Deirdre Thom Neonatal Nurse Coordinator
Content Principal investigator (slides 3-5) Delegation and delegation log (slides 6-7) Informed consent (slides 8-15) Data collection and Case Report form completion (slides 16-17) SAE and SUSAR reporting (slides 18-21)
Responsibilities for the Study team The Principle Investigator is responsible for the conduct of the study at each Site ICH Guidance for Good Clinical Practice Section 4
Investigator s Responsibilities: The Principle Investigator should: ensure that the study is performed in compliance with GCP, regulatory requirements and the I2S2 trial protocol allow monitoring / auditing / inspection by sponsor and / Regulating authorities have the time, staff and facilities to properly conduct the study report all SAE s and SUSAR s according to the I2S2 trial protocol
Investigator s Responsibilities: The Investigator may delegate tasks to other members of the team but, overall responsibility at the site always lies with the Investigator who should always be aware of how the study is progressing
Delegation by the Investigator Appropriately qualified and experienced staff may take on roles delegated by the Investigator Delegation of specific study-related tasks by the Investigator should be clearly and fully documented in the Delegation log which is kept in the Investigator Site File
From list of specific study related tasks, put the corresponding letter in this column PI MUST sign before the delegated tasks may be performed
Informed consent Written Informed consent must be obtained before any I2S2 trial-related procedures are performed Without consent: A trial participant could sue for assault Study indemnity may be invalid Ethics Committee may retract approval Trust R&D may not approve future projects
Definition of informed consent A process by which a subject voluntarily confirms his or hers willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. ICH GCP E6
How does the I2S2 trial provide the relevant information? Mothers will be given an Ethics approved participant information sheet (PIS), for I2S2; there are full and abridged versions, the abridged version is not a substitute for the full version The I2S2 Nurse or PI should discuss the study with the parents, giving them time to consider participation and answer any questions they may have
Informed consent Parents should have enough time to consider if they want their infant to take part in I2S2, we recommend at least 24 hours if possible (we have 42 hours from birth to include and randomise an infant in the study)
Who can take informed consent? The I2S2 Nurse or Principal Investigator Other members of the team may also take consent. They must be delegated to perform this task by the Principal Investigator, which must be recorded on the Delegation log in the Investigator Site File Any person taking consent should be appropriately qualified and experienced to perform this task The person should have knowledge and understanding of the I2S2 trial and ICH GCP
Documenting consent Once consent has been obtained, send the original consent form to NPEU CTU, file a copy in the Investigator Site file, the infants medical notes and the final copy is for the parents Attach a copy of the PIS to the consent form that you file in the medical notes and the one you give to the parents. Make an entry in the medical notes that the infant has been consented and entered in the I2S2 Study, always record the date and time.
Withdrawal of consent Parent(s) may withdraw consent at any time without giving a reason No more study related procedures may be performed without parental permission (except as necessary for patient safety) Infants in I2S2 may be withdrawn from I2S2 solution. Assessment, data and blood collection may continue this should be explained to the parent when the decision is made to discontinue I2S2 solutions before 34 +0 weeks; all decisions should be documented in the medical notes and I2S2 trial Form 4
Data protection All information collected will be kept strictly confidential, but... Medical notes may be inspected by the sponsor / regulatory authorities / Ethics Committee / Trust this is explained in the participant information sheet Patient s GP will be informed of participation (with consent) by NPEU, CTU
Data collection What is source data? original documents, data and records (e.ge hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automatic instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, X- rays, subject files and records kept at pharmacy, at the laboratories and at the medico-technical departments involved in the clinical trial Definition ICH section 1.52
Case report form completion Case report forms should always be completed using black ink Data should be entered with a clear date, time and signed by the person making the entry Any changes or corrections should be dated, initialled and explained (if necessary) The correction should not obscure the original entry (maintain an audit trial) Applies to both written and electronic data
SAE and SUSAR reporting If you suspect that an SAE or SUSAR has occurred it should be reported to the Sponsor within 48 hours of becoming aware of the event Refer to Protocol and guidance sheet 11 to check if SAE should be reported to sponsor Report any suspected SAE s and SUSARS for 2 weeks after infant has completed the study or 2 weeks after withdrawal
What is a SAE? Serious Adverse Event (SAE) is defined as an adverse event that: Results in death Is life threatening Requires in-patient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability or incapacity Is a congenital anomaly / birth defect
Suspected Unexpected Serious Adverse Reaction (SUSAR) What is a SUSAR? Suspected Unexpected Serious Adverse Reaction (SUSAR) is defined as any suspected unexpected adverse reaction to the I2S2 interventions that is unexpected or serious
Form 3: SAE and SUSAR form Guidance sheet Guidance sheet 11, Version 4, 1 Dec 2009
Contacts Dr Fiona Williams Coordinating Investigator Tel: 01382 420117 E: f.l.r.williams@cpse.dundee.ac.uk Deirdre Thom I2S2 Neonatal Nurse Coordinator Tel: 01382 420124 Mobile: 07507 631 530 E: d.thom@cpse.dundee.ac.uk Kayleigh Morgan Trial Coordinator (NPEU CTU) Tel: 01865 617923 E: Kayleigh.Morgan@npeu.ox.ac.uk