Study name:
Study code:
EudraCT number:
Sponsor / Investigator
Name of study site:
Date of monitoring visit:
PERSONNEL PRESENT DURING THE VISIT
Name / Position in the study
(PI, co-investigator, study nurse)
- Protocol and amendments
1.1Has the protocol (and amendments) been signed and dated by sponsor / investigator?
1.2Has the head of department / research approved the trial?
Comments:
- Ethics committee and Regulatory authorities
2.1Has the Ethics Committee statement for study protocol (and amendments) been obtained and available at the site?
2.2Has the Ethics Committee statement for study documentation been obtained and available at the site?
Document: / Version number:
- Case Report Forms
- Patient Information Sheet
- Informed Consent Forms
- Other written information provided to the subjects
- Advertisement for subject recruitment
- Other, specify:
2.3Has the regulatory authority notification been done as appropriate?
2.4Have any other applicable authorities been notified appropriately?
Comments:
- Trial Staff
3.1Has the list of delegated trial related duties and signatures for relevant trial staff been made?
3.2Was updated and signed Curriculum Vitae available for the investigator and each subinvestigator?
3.3Are all members of the trial staff informed of the trial and qualified to carry out their trial related duties?
Comments:
- Resources
4.1Does the site have adequate resources to carry out the trial?
4.2Has a budget and funding proposal been prepared?
4.3Have insurance agreements been made?
Comments:
- Agreements
5.1Have agreements been made concerning relevant associated functions?
- Laboratory
- Pharmacy
- Pharmaceutical company
- Other, specify:
Comments:
- Facilities / Equipment
6.1Are the general facilities at the site appropriate for the study?
6.2Does the site have the necessary equipment?
6.3Have instructions for the use of relevant equipment been prepared?
6.4Have quality assurance procedures been established for relevant equipment, including calibration?
6.5Concerning multi-centre trials, were the necessary steps taken to ensure that data/results are comparable?
Comments:
- Laboratory samples (if not applicable to this study, proceed to next section)
7.1Did the laboratory have a certificate of analysis?
7.2Were the reference values for relevant analysis present?
7.3Were the procedures for handling and processing relevant laboratory samples prepared (e.g. sampling, storage, shipment)?
7.4Concerning multi-centre trials, were the necessary steps taken to ensure that data/results are comparable?
Comments:
- Trial subjects
8.1Were the requirements for medical record keeping concerning participation in a clinical trial discussed?
8.2Was the procedure for recruiting trial subjects been described?
8.3Were the instructions for verbal information to be given to trial subjects been described?
8.4Were adequate supplies of informed consent forms and written information for subjects available at the site?
Comments:
- Investigational product
9.1Was the trial staff informed about the receipt/handling/storage/destruction of the investigational product?
9.2Were the procedures for IP accountability in place at the site?
9.3Was the Investigators Brochure / Summary of product characteristics present?
9.4Was the IP available at the site and supplies adequate?
9.5Was the trial staff informed about the randomisation procedures?
9.6Was the trial staff informed about the blinding and code breaking procedures?
Comments:
- Handling of adverse events
10.1Was the staff informed about the handling of adverse events and serious adverse events?
10.2Were the relevant notification forms present?
Comments:
- Study documentation
11.1Was the monitoring visit log filled?
11.2Was the document specifying source data available?
11.3Were Case Report Forms available at the site and study staff informed of their appropriate completion?
11.4Were other essential study documents present and filed in the Investigator’s file?
11.5Was the storage and archiving of data discussed?
Comments:
- Follow up
12.1Has a new visit been scheduled to the site?
12.2Has a follow-up letter been sent to the Investigator?
12.3Required actions / outstanding issues from this visit? (if yes, please specify)
Comments:
Signatures
Name of Study Monitor / Date / Signature
Name of Sponsor/Investigator / Date / Signature
Version 25.8.2010