-For Observational Studies this form is for information only. No action is required but we suggest you use this as guidance to ensure all aspects of your study are compliant with Good Clinical Practice.
-Clinical Trials of an Investigational Medicinal Product (CTIMPs) and Interventional Studies MUST return part A within 2 months of receiving R&D Approval. Completion of Part B is voluntary, however, we would suggest you use this as guidance to ensure all aspects of your study are compliant with Good Clinical Practice.
- Please note whilst completion of Part B is voluntary, compliance with all points listed is compulsory and you should be able to assure you are working in line with these.
-This form will be re-sent by the R&D Office annually to ensure compliance is maintained.
-We may choose to audit certain studies based on the information returned in Part A and whether external monitoring has been undertaken but we will be in contact in due course if this is the case.
Study Short Title:PHT Number:
Principal Investigator (PI):
Study Status: / Open to Recruitment / Closed to Recruitment-In Follow-up
Closed – Follow-up Complete / Completed (closed out)
Archived / Disseminated
Please specify (DD/MM/YYYY)
End of Recruitment Date:
Planned End Date:
Has this changed from the initial defined end dates?
SECTION A: Self Declaration
Please confirm all actions stated below have been completed or are in place. If you are unable to confirm these, please specify actions to be taken to resolve this. For further information or guidance please contact the Research Office team and visit our website for all Policies, SOPS and Templates.
Site File:
Action /Yes
/No
(please state what action will be taken to resolve)Is an Investigator Site File (ISF) being maintained and does it contain all required documentation withinit?(Please refer to PHT/RDSOP/009)
Are there any gaps in the ISF which cannot be corrected?
Is the ISF readily available for monitoring, audit and inspection purposes?
Is the ISF kept securely in a locked room/filing cabinet?
What is the location?
Is the delegation log up-to-date with all current and past staff clearly indicated?
Are all entries on the delegation log signed off by the PI?
Have all duties have been delegated appropriately?
(This decision must be made by the PI and therefore this question should be answered by them directly).
Are all the people responsible for taking informed consent appropriately trained to do so?
(Please see PHT/RDSOP/005)
Is evidence of this training available for each individual if the person taking consent is not a clinician?
Is there a CV and GCP certificate (demonstrating training within 2 years), in place for each staff member listed on the delegation log?
Are all members of staff up to date with SOPs training?
Is any study specific training required and if so, has this been documented for all appropriate staff?
Does each member of staff listed on the delegation log have a current PHT NHS contract or letter of access?
Are all the latest versions of study documentation being used and filed in the site file?
Is asigned consent form for all study participants held in the site file?
(a copy should also be filed in the participants medical notes)
Have all amendments been notified to R&D?
Have all staff working on the study been made aware of any amendments which affect their department?
Have all patients been recorded on EDGE?
Has this study been externally monitored by the study sponsor or a delegated representative within the last year?
YES
Please specify date:
Were any significant findings identified?
NO
Have you undertaken any self-monitoring? YES NO
Have any patients withdrawn / been withdrawn from the study? YES NO
(If yes please give details)
Although completion of Part B is voluntary please review the points shown below and confirm whether you are confident that you comply with all? YES NO
Comments:
SECTION B: Participant Specific Checks
Completion of Part B is voluntary, however,compliance is compulsory. Although we do not require you to pull patient notes to undertake this review please ensure you are confident that you comply with all the points listed.
If you would like to undertake this activity to assure your practice we suggest you select randomly at least 10% of recruited participantssince your last monitoring visit and pull their medical notes to physically check that the following statements are true for each participant.Indicate your response using the Yes/No/N/A boxes.
Participant specific checks:-Please specify which participants have been selected (study number & initials only):
Yes
/No
/N/A
/Comment/Action plan
Have all consent forms been signed and dated by both the participant and researcher?Is the date the same?
Has the participant initialed all the boxes rather than ticked them?
Is there a copy of the signed consent form in the patients’ notes?
Can you confirm that documentation of the consent process has been written into the patient notes?
In all cases, was consent taken prior to any study intervention?
Can you evidence this?
Has it been documented that all participants meet the inclusion criteria and avoid all exclusion criteria?And does it demonstrate that eligibility was assessed by an appropriately delegation person?
Have all participant visits occurred within the protocol specified time frames?
If no, have any missed / delayed appointments been documented and the Sponsor informed?
Where SAE reporting is required:
Have all sets of notes been checked to ensure all SAEs have been identified? (Including the review of other sets of notes i.e. Radiotherapy/Ophthalmology/ Main notes?)
Have you checked PAS to see if any new sets of notes have been created?
Is there an SAE Alert notice present in the notes (for patients seen from Jan 31st only)
Where applicable, have all Serious Adverse Events (SAES & SSARS) and Suspected Unexpected Serious Adverse Reactions (SUSARS) been reported to the study Sponsor and recorded in the patients’ notes and the site file. (Please see PHT/RDPolicy/002 & PHT/RDSOP/007)
Is there evidence of PI oversight in assessing causality and expectedness?
Do you have an up to date log of all study SAEs?
Have any serious breaches been identified?
If yes, have they been reported to the study Sponsor and PHT R&D within the agreed timeframe (within 24 hours) (Please see PHT/RDSOP/002)
Have all safety reports (investigator notifications) been signed off by the PI?
Where there have been amendments to the consent form, participant information sheet or protocol which impact on study participants and requires re-consent, have all such participants been re-consented to the new amended versions?
Have all CRFs been completed accurately and legibly?
Are all corrections made with a single line through, initialed & dated?
Do patient notes have a completed Clinical Trial Sticker inside the front cover of patient notes?
Have all samples sent to Pathology been identified with a research sticker?
Are the source documents stored in a safe and secure environment?
Please give details in the comments box
6. Staff, Facilities, Equipment & Supplies
Yes
/No
/Comment
Is there adequate staff to carry out this study safely & effectively?Are the facilities adequate to carry out this study safely and effectively?
Does the site have adequate supplies to carry out this study? e.g. CRFs, Lab-kits
Do you have any study specific equipment? Is this maintained and calibrated as appropriate?
Clinical Research Team Comments
GCP Compliance ToolCompleted by
(PRINT NAME):
Signed:
Date:
Position:
Contact telephone number:
E-mail address:
Signed by PI to confirm the information declared is correct:
R&D Team Comments
GCP Compliance ToolChecked by
(PRINT NAME):
Signed:
Date:
Position:
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Good Clinical Practice Compliance Tool – v1.0 – 13 November 2014