Amendment Log Guidance You must obtain your Sponsor’s approval before either implementing any changes or notifying other review bodies ie, NHS REC and NHS R&D. Send a copy of your updated or new documents to for Sponsor approval and categorisation of the amendment. A Non Substantial amendment Form (available on the HRA website) or Substantial Amendment Form (generated through IRAS) will then be required. Example: Document title Previous version Revised version Classification and Date of Bodies to which Approval/ number and date number and date approval by sponsor amendment has been Implementation Date A/B/C submitted Version Date Version Date Substantial number Amendment Amendment Category 001 Protocol 1 2 REC 14/01/18 Participant information 1 2 R&D 20/01/18 sheet Date: Date: PBPP 20/03/18 24/12/17 N/A Other (specify) 002 Protocol 2 3 REC 04/05/18 Participant information 2 3 R&D 05/06/18 sheet Date: Date: PBPP 10/08/18 Health Questionnaire 1 2 07/04/18 N/A Other Post ad (specify)
Amendment Log Guidance You must obtain your Sponsor’s approval before either implementing any changes or notifying other review bodies ie, NHS REC and NHS R&D. Send a copy of your updated or new documents to for Sponsor approval and categorisation of the amendment. A Non Substantial amendment Form (available on the HRA website) or Substantial Amendment Form (generated through IRAS) will then be required. Example: Amendment number Document title Previous version number and date Revised version number and date Classification and Date of approval by sponsor Amendment Category A/B/C Bodies to which amendment has been submitted Approval/ Implementation Date Version Date Version Date Substantial 001 Protocol Participant information sheet 1 1 2 2 REC 14/01/18 R&D 20/01/18 Date: 24/12/17 Date: N/A PBPP 20/03/18 Other (specify) 002 Protocol Participant information sheet Health Questionnaire Post ad 2 2 1 3 3 2 REC 04/05/18 R&D 05/06/18 Date: 07/04/18 Date: N/A PBPP 10/08/18 Other (specify)