Table 1.
The documents required for the study
| Regulator | |||||||||||||
| Data protection* | Information governance* | JRO office* | HRA REC | CAG | Named NHS site | NHS site of 1 collaborator | HQIP NICOR | HQIP PICANet | ICNARC | NHS Digital | Pages/ screens | Times submitted | |
| Study forms filled out | |||||||||||||
| Data protection form | 7 | 3 | |||||||||||
| Governance forms (online) | 1 | 1 | |||||||||||
| IRAS form | 32 | 4 | |||||||||||
| Ethics amendment form 1 | 3 | 4 | |||||||||||
| Ethics amendment form 2 | 4 | 4 | |||||||||||
| CAG form—IRAS | 40 | 5 | |||||||||||
| CAT advice form | 5 | 1 | |||||||||||
| CAG amendment form 1 | 5 | 4 | |||||||||||
| CAG amendment form 2 | 6 | 4 | |||||||||||
| HQIP form including partner form | 29 | 3 | |||||||||||
| HQIP form (PICANet) | 24 | 1 | |||||||||||
| ICNARC form | 5 | 1 | |||||||||||
| DARS form (online) | 21 | 1 | |||||||||||
| Data fields and justification (NICOR) | 4 | 1 | |||||||||||
| Data fields and justification (PICANet) | 4 | 1 | |||||||||||
| Data fields & justification (ICNARC) | 4 | 1 | |||||||||||
| Data linkage diagram | 1 | 9 | |||||||||||
| Detailed data linkage diagram | 1 | 1 | |||||||||||
| Risk assessment | 3 | 3 | |||||||||||
| IG toolkit confirmation | 1 | 8 | |||||||||||
| Correspondence with NICOR | 1 | 2 | |||||||||||
| Correspondence with charities | 1 | 1 | |||||||||||
| Letter from SIRO | 1 | 3 | |||||||||||
| Privacy notice | 2 | 9 | |||||||||||
| Protocol | 25 | 6 | |||||||||||
| Insurance registration form | 6 | 1 | |||||||||||
| Statement of activities | 22 | 4 | |||||||||||
| Organisational info document | 7 | 4 | |||||||||||
| Cover letter × 3 | 3 | 2 | |||||||||||
| Checklist | 2 | 2 | |||||||||||
| Documents organised/shared | |||||||||||||
| HQIP letter of support | 1 | 3 | |||||||||||
| Insurance certificate | 1 | 2 | |||||||||||
| REC provisional opinion | 5 | 2 | |||||||||||
| REC favourable opinion | 4 | 8 | |||||||||||
| Ethics amendment 1 approval | 1 | 5 | |||||||||||
| Ethics amendment 2 approval | 1 | 5 | |||||||||||
| CAG provisional approval | 8 | 4 | |||||||||||
| CAG approval | 6 | 8 | |||||||||||
| CAG amendment 1 approval | 3 | 5 | |||||||||||
| CAG amendment 2 approval | 5 | 6 | |||||||||||
| Funder contract | 38 | 2 | |||||||||||
| PI CV | 4 | 4 | |||||||||||
| CV’s from team | 10 | 1 | |||||||||||
| Reviewers comments | 4 | 4 | |||||||||||
| HRA/HCRW approval letter | 4 | 7 | |||||||||||
| Training certificates | 5 | 1 | |||||||||||
| Service agreement | 14 | 1 | |||||||||||
| Total documents required | 2 | 3 | 25 | 22 | 19 | 32 | 23 | 8 | 8 | 11 | 13 | 384 | 162 |
Block shading indicates documents required for each corresponding regulator. The ‘times submitted’ column sums the number of times each document was required by a different regulator.
*Processes as at UCL.
CAG, Confidentiality Advisory Group; CAT, Confidentiality Advice Team; CV, curriculum vitae; DARS, Data Access Request Service; HCRW, Health and Care Research Wales; HQIP, Health Quality Improvement Partnership; HRA, Health Research Authority; ICNARC, Intensive Care National Audit and Research Centre; IG, information governance; IRAS, Integrated Research Application System; JRO, Joint Research Office; NHS, National Health Service; NICOR, National Institute for Cardiovascular Outcomes Research; PI, principal investigator; PICANet, Paediatric Intensive Care Audit Network; REC, research ethics committee; SIRO, Senior Information Risk Owner; UCL, University College London.