BSTOP Amendment 2019
These are the documents relating to Substantial Amendment 5 (SA05) and Minor Amendment 12 (MA12) approved in Summer 2019 which...
Here you can find all the important documents and forms for BSTOP. If you are in doubt of the correct document versions you should be using, get in touch with the study team at BSTOP@gstt.nhs.uk.
Core Study Documents
| Document name | Version | Notes |
|---|---|---|
| BSTOP Protocol (pdf, 996 KB) |
v8 02 Oct 2023 | Used for all patients |
| Informed Consent Form (doc, 50 KB) |
v7 30 Jun 2023 | |
| Patient Information Sheet (doc, 47 KB) |
v7 30 Jun 2023 | |
| Patient Invitation Letter (doc, 20KB) |
v3.1 01 Mar 2023 | |
| Withdrawal of Consent form (doc, 37KB) |
v1.1 01 Mar 2023 | To be used for participants consented to PIS/ICF 4.1 or earlier |
| Withdrawal of Consent form (doc, 37 KB) |
v2.2 01 Mar 2023 | To be used for participants consented to PIS/ICF v5.1 or later |
| BSTOP File Note Template (doc, 45 KB) |
v3 08 Sep 2023 |
Used to describe and document any deviations, problems, or unexpected events occurring during the conduct of research |
| BSTOP Sponsor Contact Sheet (pdf, 366KB) |
v4 08 Sep 2023 |
Sample Management
| Document name | Version | Notes |
|---|---|---|
| SOP for BSTOP Partner Sites | v1.1 19 Apr 2023 | The SOP for BSTOP partner sites is here to guide you through sample collection, processing, storage and shipping. Please refer to this SOP in the first instance and get in touch if your query is not covered. |
CRF and Sample Request Forms
All patient visits require a completed CRF and all samples require a completed sample request form.
If you are in any doubt about which forms you should be using, please contact the main coordinating site. The current version of the CRFs is 12.1.
Single Sample Sites (DNA only)
For sites collecting blood for DNA only, including all patients at PSORT-D sites if the patient is being recruited to the BSTOP study.
| Document name | Version | Notes |
|---|---|---|
|
BSTOP Not on BADBIR Baseline CRF |
v12.1 16 Feb 2024 | To be used for patients not enrolled on BADBIR |
| BSTOP on BADBIR Baseline CRF (pdf, 511 KB) |
v12.1 16 Feb 2024 | To be used for patients who are already enrolled on, or about to enrol on, BADBIR |
| BSTOP Sample Request Form DNA-only (pdf, 598 KB) |
v7.0 16 Feb 2024 | For all sites |
Former PSORT-D Sites
For sites that are still following up PSORT-D patients under the BSTOP study. Note - changes to the BSTOP protocol mean that all PSORT-D patients are eligible for BSTOP whether they are participating in BADBIR or not.
| Document name | Version | Notes |
|---|---|---|
| BSTOP on PSORT-D Follow Up CRF (pdf, 438 KB) |
v11 08 Mar 2023 | To be used at follow up visits for former PSORT-D patients being followed up under BSTOP. |
| BSTOP Sample Request Form PSORT-D (pdf, 669 KB) |
v7.0 16 Feb 2024 | For former PSORT-D sites |