Resources
Please find below ATM Trial Investigator Site File materials and version log to support completing the Trial Closure Checklist.
Click on the Relevant Amendment Number for all documents and approvals.
ATM Version Log V26.0
ATM Site Closure Checklist (Template)
ATM Investigator Site Closure Form (Template)
Amendment No.
|
Details of Amendment |
Site Trial Documents Included |
|---|---|---|
20
|
Protocol, PIS and consent from updated to include 6 month no cost extension. Study document updated with clarification regarding the use of next of kin contact information and the use of text messaging to contact participants. Participant letters updated to include signposting to the trial website for updates about the study and related statement. |
|
19
|
Additional quality assurance procedures to verify the quality of the PRP preparation |
|
18
|
Amendment was generated in response to new guidelines in Biologics for Orthopaedics which were published 2017. Addition of quality assurance checks and analysis of the PRP samples created using the ATM method. |
|
17
|
N/A - RECALLED |
N/A -Recalled |
1618.12.2018Non-Substantial Amendment |
Recruitment end date updated in protocol to Nov 2019. All follow up questionnaires and letters updated with new trial office contact details. |
|
15
|
Additional recruitment centre |
N/A – Non-Substantial amendment documents did not relate to sites |
14
|
Minor changes to wording in unblinding letters. New cover letter for posting participant £5 reward vouchers. |
N/A – Non-Substantial amendment documents did not relate to sites |
13
|
Additional recruitment centre |
N/A – Non-Substantial amendment documents did not relate to sites |
12
|
Additional recruitment centre |
N/A – Non-Substantial amendment documents did not relate to sites |
11
|
Addition of PIC site. Email from REC – amendment 11 not required already have PIC approval. |
N/A – Non-Substantial amendment documents did not relate to sites |
10
|
New timeline for 20 sites and 0.5 monthly target amendment to Protocol. Text messaging templates used by data clerk for follow up data collection. |
|
09
|
Change to PI, return form maternity leave. Additional sites 15 to 20 |
|
08
|
Protocol update to exclusion criteria. Created 6-month unblinding letter. |
|
07
|
3-and 6-month questionnaires updated - complications data section added to ensure no duplicating data collection over time points. Reminder letter for 6-month questionnaire created. |
|
06
|
Minor Protocol amendment |
|
05
|
4 additional recruitment centres |
N/A – Non-Substantial amendment documents did not relate to sites |
04
|
Minor changes to the protocol to reflect recommendations made by the TSC. The number of centres to be recruited was increased to 14 and therefore the recruitment target per centre per month was reduced to 0.6 patients per centre per month. |
|
03
|
3- and 6-month questionnaires created for bilateral patients to capture complications data on both tendons. |
|
02
|
Minor changes to the protocol and supporting documents to reflect recommendations made by the TSC. |
|
01
|
Minor changes to the Protocol and supporting documents. |
|