• Roles and responsibilities of the blinded and unblinded study teams should be clearly segregated.
• Site staff should be delegated on the Signature Sheet.

Applicable references: GCP 5.14.3

• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Check the physical inventory against the IP Inventory Log on a regular basis.
• The IP Inventory Log should not be completed electronically, unless the inventory is managed by a validated electronic system.

• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Check the physical inventory against the IP Inventory Log on a regular basis.
• The IP Inventory Log should not be maintained electronically, unless the inventory is completed by a validated electronic system.

• Site staff involved in IP repackaging should be part of an unblinded study team.
• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Separate IP Inventory Logs should be maintained for each IP.
• The IP Inventory Log should be filed in the Pharmacy Binder, where access is secure and limited to the unblinded study team in order to maintain the study blind.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Check the physical inventory against the IP Inventory Log on a regular basis.
• The IP Inventory Log should not be completed electronically, unless the inventory is managed by a validated electronic system.
• All correspondences concerning IP Management that may potentially unblind the study should be limited to the unblinded study team.

Applicable references: GCP 4.6.3

• With individual kit numbers55 KB
• Without individual kit numbers55 KB

• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Check the physical inventory against the IP Inventory Log on a regular basis.
• The IP Dispensing and Accountability Log should not be completed electronically, unless the inventory is managed by a validated electronic system.

• Site staff involved in IP repackaging should be part of an unblinded study team.
• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Check the physical inventory against the IP Inventory Log on a regular basis.
• The IP Dispensing and Accountability Log should not be completed electronically, unless the inventory is managed by a validated electronic system.

• Site staff involved in IP repackaging should be part of an unblinded study team.
• Ensure there are written procedures available for IP Repackaging and Relabelling.
• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Site staff involved in IP Repackaging and Relabelling should be trained accordingly.
• A witness, who is part of the unblinded study team, should observe the IP Repackaging and Relabelling process.
• Line clearance should be observed such that one type of IP is repackaged and relabelled at a time to avoid any mix up.
• The quantity of the IP labels should be reconciled and documented on the IP Repackaging and Relabelling Form.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• The IP Inventory Logs should be updated for IP Repackaging and Relabelling.
• The IP Repackaging and Relabelling Form should be filed in the Pharmacy Binder, where access is secure and limited to the unblinded study team in order to maintain the study blind.
• All correspondences concerning IP Management that may potentially unblind the study should be limited to the unblinded study team.
• The IP Repackaging and Relabelling Form should not be completed electronically.

• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• The IP meant for destruction should be kept separately from the unused IP.
• The IP Destruction Form should not be maintained electronically, unless the inventory is completed by a validated electronic system.

• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Ensure that the thermometer used for monitoring the IP storage temperature is calibrated and maintained regularly. Copies of the calibration and maintenance records should be filed in the Investigator Site File.
• Record the serial number of the thermometer on the IP Storage Temperature Log for traceability purposes.

• Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

• Superseded essential documents (e.g. protocol, Investigator’s Brochure, Informed Consent Form templates) should not be removed from the Investigator Site File. A copy of the superseded essential documents should be marked ‘Superseded’ and retained in the Investigator Site File.
• A note to file should be placed in the relevant section of the Investigator Site File if the essential document has been filed elsewhere.
• Check that all essential documents are complete, accurate, legible and current.

Applicable references: GCP 4.9.5, Section 8

• Signed protocol signature pages should be present for the approved protocol and subsequent amendments used at the site.

• The Trial Participant Identification Log is a confidential document that should be maintained in the Investigator Site File. It should not be circulated to the Sponsor, IRB, HSA or other third parties.
• Ensure that the Trial Participant Identification Log is updated in a timely manner whenever a new trial participant is enrolled into the clinical trial.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

Applicable references: GCP 8.3.21

• Ensure that the log is updated in a timely manner whenever there is a new trial participant screened or enrolled into the trial.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

Applicable references: GCP 8.3.20, 8.3.22

• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

• The Principal Investigator should ensure that the site staff is adequately qualified by education, training and experience to perform the delegated duties.
• Site staff should be appropriately trained prior to conducting any study procedures.
• Sub-investigators should only be included in the study team after written IRB approval has been sought.
• It would be recommended that the trial-related activity of obtaining informed consent be delegated to an investigator who is a qualified practitioner or qualified pharmacist, adequately qualified by education, training and experience to determine the trial participant's eligibility for enrolment into the clinical trial and address any questions that the trial participant may have in a satisfactory manner.
• The Signature Sheet should be updated in a timely manner whenever there is a change to site staff or delegated duties.
• The name, initials and signature of the site staff on the Signature Sheet should be consistent with all other essential documents.
• In the event of a change in Principal Investigator during the course of a clinical trial, it would be recommended to update the previously signed Signature Sheet with an end date for each site staff, and to complete a new Signature Sheet for the new Principal Investigator to authorise the site staff.
• All versions, including superseded versions, should be present in the site file.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

Applicable references:

• Regulation 23(3) of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations
• GCP 2.8, 4.1.5, 4.2.4, 4.9.1, 8.3.24

• Training records for all site staff delegated in the Signature Sheet should be present in the site file.
• It would be recommended to file the following training documentation for all site staff in the Investigator Site File, where applicable:
  • Investigator Meeting
  • Site Initiation Visit
  • Collaborative IRB Training Initiative (CITI)
  • Good Clinical Practice (GCP)
  • Protocol-specific training

• Ensure that the safety reporting requirements are detailed in the protocol.
• Ensure that SAEs are notified to the Sponsor, IRB and HSA (where applicable) in accordance with their respective safety reporting requirements.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Ensure that the SAE Tracking Log is updated in a timely manner.

Applicable references:

• Regulations 24 and 25 of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations
• GCP 2.3, 4.11, 5.16, 5.17, 8.3.16-18

• Always check that the required approval for the study documents had been obtained prior to using them at site.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Ensure that the log is updated in a timely manner.

Applicable references: GCP 4.4.1, 4.4.3

• Serious breaches of the principles of GCP or trial protocol or clinical trials regulations must be notified to HSA.
• A serious breach is a deviation which is likely to affect to a significant degree: (a) the safety or physical or mental integrity of any trial participants in a clinical trial, or (b) the scientific value of the clinical trial.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Ensure that the log is updated in a timely manner.

• Regulation 11 of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations
• GCP 4.5.3

• Always check that trial participants have been consented with the latest approved informed consent form in a timely manner.
• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Ensure that the log is updated whenever an informed consent form is signed.

• Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
• Ensure that the log is updated in a timely manner.

Applicable references: GCP 8.3.25