New Content – Prescribing for Tumour Associated Epilepsy
Spring Trial background
Spring Trial eCRF Training
Investigator Site File Contents
1 Contact Information
Sponsor CI details V2.0Sponsor
Clinical Trials Unit Details v6.0
2 Study Correspondence
Site Newsletter 02 8th Oct 2020
Site Newsletter 03 21 Apr 2021
3 Protocol and Amendments
3 a Current Protocol
SPRING Protocol V9.0 29 March 2023 (clean)
SPRING Trial Synopsis V8.0 13th May 2021
3b Superseded protocols
SPRING Protocol V6.2 25 Sep 2019
SPRING Protocol V6.3 07 Apr 2020
SPRING Protocol V7.0 29 June 2020
SPRING Protocol V8.0 24 May 2021
SPRING Trial Synopsis V6.0 15 May 2019
SPRING Trial Synopsis V7.0 29 June 2020
3c PI Statements
PI Declaration V9.0 29th March 2023
PI Declaration V8.0 24th May 2021
PI Declaration V7.0 29 Jun 2020
PI Declaration V6.3 07 Apr 2020
PI Declaration V6.2 25th Sep 2019
4 Ethics
4a Favourable Opinion
Ethics approval (re-issued) Feb 2019
4b Substantial Amendments Approvals
SA01 Ethics Approval letter18 Jun 2018
SA02 Ethics Approval letter15 Oct 2019
SA03 Ethics Approval letter 24 Apr 2020
SA05 Ethics Approval letter reissued 05 Aug 2020
SA06 Ethics Approval letter 08 Jul 2020
SA07 Amended Favourable Opinion
SA08 Ethics Approval letter 09 Mar 2021
4c Initial IRAS Applications & Cover letters
1 Ethics Cover Letter 07 Nov 18
2 Ethics Cover Letter 20 Nov 18
2 Provisional Approval 20 Dec 18
3 Ethics Cover Letter 14 Jan 19
4 Ethics cover letter 01 Feb 19
4 IRASForm_snapshot 4th Feb 2019
4d Amendment Applications & Cover letters
Substantial Amendments
SA02 Ethics cover letterSA02 IRAS form
Non-Substantial Amendments
4e Annual Progress Reports
5 HRA – Sponsor
5a HRA Study Approval
HRA HCRW Letter of Approval – 30.04.2019
5b HRA Substantial Amendment Approval
5c Trial Indemnity
2018-2019 cnoris_confirmation_of_cover
2019-2020 cnoris_confirmation_of_cover
2020-2021 cnoris_confirmation_of_cover
2021-2022 cnoris_confirmation_of_cover
2022-2023 cnoris_confirmation_of_cover
2023-2024 cnoris-confirmation-of-cover
6 Regulatory MHRA
6a CTA Approval
6b Substantial Amdt Approvals
6c Initial CTA Application
1 MHRA cover letter 01 Oct 20181
2 MHRA cover letter 07 Nov 2018
3 MHRA cover letter 27 Nov 2018
3 MhraProductsForm_ReadyForSubmission
4 MHRA Cover Letter 01 Jan 2019
6d Amendment applications & Letters
SA01 MHRA cover letter – (resubmission)
SA01 MhraProductsForm_snapshot
SA02 AmendmentFormMHRAEudract_snapshot
SA05 AmendmentFormMHRAEudract_snapshot
SA06 MhraProductsForm_ReadyForSubmission
7 Critical Documents – ISF
7f Labels
SPRING TRIAL LABELS DESIGN_v1 02 10 2018
SPRING TRIAL LABELS DESIGN_v2 14Jul2020 Clean
7h Visit Schedule
Patient Visit Schedule – Protocol V8.0
7k Pharmacy Manual
8 Trial Documents
a Patient Information Sheet
Patient information and consent V6.0 15 May 2019
Patient information and consent V6.1 07 Apr 2020
Patient information and consent V7.0 17 Aug 2020
Patient information part one V1.0 24 May 2021
Patient information and consent – part two V8.0 24 May 2021
List of Side Effects v1.0 24th May 2021
Patient Invitation letter v1.0
Patient Invitation letter v2.0
Telephone Patient informed consent V1.0 24 Jun 2020
Telephone Patient informed consent V2.0 24 May 2021
8b Carer Information sheet
Carer PIS_ICF V5.0 09 May 2019
Carer PIS_ICF V6.0 17th Aug 2020
Carer PIS_ICF V7.0 26 Oct 2022 Clean
8c GP Letter
8d Patient ID Log
SPRING Patient Identification Log Sep 2019
8e Other Trial Documents
Seizure guidance V1.0 27 Sep 2018
Seizure Diary V2.0 26 June 2020
Starting medication V4.0 13 May 2021
Finishing medication V2.0 26 June 2020
Reduced Dose Tablet tracker V3.0
Patient Leaflet v2.0 22 Jul 2020
8g Patient Invitation Log
Patient Invitation Log V1.0 21 Nov 2019
Patient Invitation Log V2.0 23 Nov 2020
10 Pharmacovigilance
Pregnancy follow-up form v1.0 15th July 2019
Spring SAE form v1.0 14th June 2019
Spring SAE form v2.0 21 Oct 2020
Safety Reporting Guidelines File Note
11 Case Report Forms
Database User Manual File Note
Spring site work instructions v1.0 10 October 2019
Spring site work instructions v2.0 25 November 2020
Spring Redcap Instructions v1.0 06 October 2021
MRI – Baseline data collection v1.0 28 June 2019
MRI – Post surgery data collection v1.0 28 June 2019
MRI – Follow up data collection v1.0 28 June 2019
Follow-Up Visit Checklist V4.0
13 GCP
Declaration of Helsinki File note
SPRING SIV Slides V8.0 08th July 2022 print version
14 Pharmaceutical Information
15 File Notes
Spring File note template v2.1 04 Nov 2020
Pharmacy Site File Contents
1 Contact Information – see ISF section 1
2 Study Correspondence – see ISF section 2
3 Protocol and Amendments – see ISF section 3
7 IMP – see ISF section 14
8 Critical Documents – see ISF section 7k Pharmacy Manual
10 Certificates and Reports
AUTORISATION GMDP 194 H – FEVRIER 2018
C3499_Non animal origin_Statement
GMP Compliance Certificate MIA (IMP) 19055 – 03 11 2016
Licence MIA (IMP) 19055, version 16, 2016
Safety Data Sheet – Levetiracetam(102767-28-2)
Shipment 1 – 20 Feb 2019
Packing list 500mg 20 Feb 2019
Packing list 250mg 20 Feb 2019
Shipment 2 – 20 April 2021
Shipment 3 – 29 Nov 2021
Packing list C4038 250 mg 29 Nov 2021
QP Statement C4038 Batch 334343 250 mg
Shipment 4 – 21 Jul 2022
Packing list C4166_2016-110268 12 Jul 2022
QP statement Certificate of Compliance batches C4166 18 Jul 2022
CofA 250mg batch 346425 24 Feb 2022
CofA 500mg batch 351093 10 May 2022
11 GCP and Monitoring – see ISF section 13
12 File Notes –see ISF section 15