Form 1 - SUHT Investigator’s Template for recording ...



Form 1 - SUHT Investigator’s Template for recording research Adverse Events (Page of )

|Full title of Study: |

|Ethics No: | |SUHT R&D no: |RHM |

Sheet number : of

|AE No: |Patient ID |Description of Event |Start date |Duration/End date |Outcome |**Sequelae |

|Assessment | |

|Intensity: | mild |Expectedness | expected | |

| |moderate | |unexpected i.e. not described in protocol, product information or | |

| |severe | |investigator brochure. | |

|Causality: | not related |Seriousness | Not serious | |

|Relationship to study |unlikely to be related | |Results in death* | |

|drug/device/intervention |possibly related | |Life threatening* | |

| |probably related | |Results in hospitalisation or prolongation of existing hospitalisation* | |

| |definitely related | |Results in disability or incapacity* | |

| | | |Congenital anomaly or birth defect* | |

| | | |Other (please specify)* | |

|AE No: |Patient ID |Description of Event |Start date |Duration/End date |Outcome |**Sequelae |

|Assessment | |

|Intensity: | mild |Expectedness | expected | |

| |moderate | |not expected i.e. not described in protocol, product information or | |

| |severe | |investigator brochure. | |

|Causality: | not related |Seriousness | Not serious | |

|Relationship to study |unlikely to be related | |Results in death* | |

|drug/device/intervention |possibly related | |Life threatening* | |

| |probably related | |Results in hospitalisation or prolongation of existing hospitalisation* | |

| |definitely related | |Results in disability or incapacity* | |

| | | |Congenital anomaly or birth defect * | |

| | | |Other (please specify)* | |

* Event is considered serious – report to the sponsor and SUHT R&D department within 24 hours using the form provided. Where none is provided use the SUHT Research Related SAE/SUSAR Initial Report Form.

Instructions Page 1 of 1

RESEARCH RELATED SAE/SUSAR REPORT FORM

Instructions for completion

(drugs, devices and interventions)

| |

|An event/reaction is serious if it: |

|results in death, |

|is life threatening, |

|results in persistent or significant disability/incapacity, |

|requires hospitalisation, |

|prolongs a current hospitalisation |

|results in a congenital anomaly or birth defect. |

This form must be used where SUHT is the Sponsor or Co-sponsor of the research study in which the SAE has occurred or where no other form has been provided by the sponsor.

Instructions for completion of Initial and Follow up Report Forms (Appendices 3 & 4):

1. As soon as possible, and at the latest within 24 hours of becoming aware of event,

• Complete the Initial Report Form and send to Sponsor.

• Where SUHT is sponsor or co-sponsor;

• email (R&Doffice@suht.swest.nhs.uk) OR

• fax (023 8079 8678) one copy to the R&D Office

Please ensure that all sections have been completed.

2. As soon as possible, and at the latest within 5 days of becoming aware of the event,

• Complete the Follow up Report Form and send to Sponsor.

• Where SUHT is sponsor or co-sponsor;

• email (R&Doffice@SUHT.swest.nhs.uk) OR

• fax (023 8079 8678) one copy to the R&D office

Please ensure that for SUSARs, all sections have been completed, and for other SAEs that sections 1, 2 and 3 have been completed.

NB: Points 1 and 2 may be done together, if within 24 hours of becoming aware of the event.

3. Complete and return (as above) further Follow-up Report Form(s) for data collected later than 5 days post SAE until the SAE has resolved or a decision for no further follow up has been taken.

4. Send a paper copy of the Initial and Full Report Forms with signatures to Sponsor. Where SUHT is sponsor or co-sponsor send to the SUHT, R&D Department, Duthie Building (Trust), Ground Floor, SGH, Tremona Road, Southampton, Hants, SO16 6YD (not required if signatures on faxed copy).

5. For multi-centre studies where CI is not investigator making this report, send a copy of each form to the Chief Investigator.

6. Send a copy each form to other bodies as required. e.g. Data safety monitoring board.

7. Keep original forms in Investigator Site File (ISF).

|R&D use only: case reference number | |Date report received by | |

| | |R&D | |

FORM 2 - RESEARCH RELATED SAE/SUSAR INITIAL REPORT FORM (Page 1 of 4)

|1. Person making report |

|Name: |      |

|Job title/role in study: |      |

|Contact address: |      |

|Email address: |      |

|Telephone No: |      |

|Fax number: |      |

|2. Details of study |

|Full Title of Study:       |Study site (e.g. |

| |Hospital name):       |

| | |

| | |

| | |

| | |

| | |

| |SUHT R&D No: RHM       |

| |Ethics No:       |

| |EudraCT No |

| |(IMP studies only):      |

|3. Details of subject affected by SAE/SUSAR |

|Subject study ID |Hospital Number |Initials |DOB |Gender |Weight |Height |

|      |      |      |      |      |      |      |

|4. Details of SAE/SUSAR (further space available in section 12) |

|Full description of event/reaction, including body site, reported signs and symptoms and diagnosis where possible:       |

| |

| |

| |

| |

| |

| |

| |

| |

| |

|Event is defined as serious because it (tick as many as apply): |*Specify: |

|resulted in death | |

|is/was life-threatening | |

|resulted in persistent or significant disability/incapacity | |

|required hospitalisation | |

|prolonged an ongoing hospitalisation | |

|resulted in a congenital anomaly or birth defect | |

|other – please specify* | |

|Please give further details in section 6 ‘Outcome’ | |

|Maximum intensity (up until time of initial report) |Mild |Moderate |Severe |

|Onset Date |Onset Time |End date |End time |OR Duration |

|(when event became serious) | | | | |

|      |      |      |      |      |

Signature of person making report:_________________________Date:____/____/____ Cont. next page

|R&D use only: case reference number | |

|To be completed by the person filling in the SAE form |

|SUHT R&D no.: |RHM       |Subject ID/initials |      |Onset date of SAE |      |

FORM 2 - RESEARCH RELATED SAE/SUSAR INITIAL REPORT FORM (Page 2 of 4)

|5. Details of IMP/device/intervention(s) if applicable (further space available in section 12) |

|Name of drug/device/intervention |Total daily dose |Dosing regime (inc route) |Date/time of last |

| |(if applicable) | |dose/intervention |

|      |      |      |      |

|      |      |      |      |

|      |      |      |      |

|      |      |      |      |

|      |      |      |      |

|6. Outcome (further space available in section 12) |

| Resolved* | Ongoing* | Died* (give cause and PM details if available) |

|*Give details:       |

|Was the patient withdrawn from the study? |Yes |No |

|7. Location of (onset of) SAE (further space available in section 12) |

|Setting (e.g. hospital*, home, GP, nursing home):       |

| |

|*If SAE occurred on SUHT precinct give exact location:       |

| |

|8. Action taken and further information (further space available in section 12) |

|Please describe action taken:       |

| |

| |

| |

| |

| |

| |

| |

| |

| |

| |

|Other information relevant to assessment of case e.g. medical history, family history, test results.      |

| |

| |

| |

| |

| |

| |

| |

| |

| |

Signature of person making report:_________________________Date:____/____/____ Cont. next page

|R&D use only: case reference number | |

|To be completed by the person filling in the SAE form |

|SUHT R&D no.: |RHM       |Subject ID/initials |      |Onset date of SAE |      |

FORM 2 - RESEARCH RELATED SAE/SUSAR INITIAL REPORT FORM (Page 3 of 4)

|9. Causality and Expectedness (to be completed by physician) |

|Is the SAE related to the |*If possibly, probably or definitely related, was |In addition to this form, and within 5 days: |

|drug/device/intervention? |the SAE unexpected? |1 - Please complete and return all sections of the |

|Not related2 |Yes1 |follow up report form. |

|Unlikely to be related2 |No2 | |

|Possibly related* | |2 - Please complete and return sections 1, 2 and 3 of |

|Probably related* |(Unexpected means not described in the protocol or|the follow up report form. |

|Definitely related* |other product information) | |

|For blinded studies: |

|Has the randomisation code been broken in making this assessment: Yes* No |

|*If yes, give details of randomisation:       |

|10. Sponsor notification (only complete where sponsor or co-sponsor is not SUHT) |

|Has the Sponsor been notified of the SAE/SUSAR? | Yes, give date:       |

| |No+ |

|+Please note, you must inform the Sponsor within 24 hours of becoming aware of the event. |

|11. Chief/Principal Investigator, or delegated physician (at this site) |

|Name: |      |

|Job title/role in study: |      |

|Contact address: |      |

|Email address: |      |

|Telephone No: |      |

|Fax number: |      |

|Signature: | |

|I confirm that the contents of this form (pages 1, 2, 3 ± 4) are accurate and complete |

Please tick this box if section 12 (next page) has been used:

Signature of person making report:_________________________Date:____/____/____ Cont. next page

|R&D use only: case reference number | |Date Received | |

|To be completed by the person filling in the SAE form |

|SUHT R&D no.: |RHM       |Subject ID/initials |      |Onset date of SAE |      |

FORM 2 - RESEARCH RELATED SAE/SUSAR INITIAL REPORT FORM (Page 4 of 4)

|12. Additional information (refer to section number) |

|Section no. |Further information |

|      |      |

|      |      |

|      |      |

|      |      |

|      |      |

Signature of person making report:_______________________________Date:____/____/____

|R&D use only: case reference number | |Date Received | |

|To be completed by the person filling in the SAE form |

|SUHT R&D no.: |RHM       |Subject ID/initials |      |Onset date of SAE |      |

FORM 3 - RESEARCH RELATED SAE/SUSAR FOLLOW UP REPORT FORM (Page 1 of 3)

|1. Further details of SAE/SUSAR |

|Further details of event/reaction, including body site, reported signs and symptoms and diagnosis where possible:       |

| |

| |

| |

| |

| |

|Maximum intensity (up until time of follow up report) |Mild |Moderate |Severe |

| |End date |End time |OR Duration |

| |      |      |      |

|2. Outcome |

| Resolved* | Ongoing* | Died* (give cause and PM details if available) |

|*Give details:       |

| |

| |

|Was the patient withdrawn from the study? |Yes |No |

|3. Additional action taken and further information since initial report |

|Please describe further action taken:       |

| |

| |

| |

| |

| |

|Further information or missing data relevant to assessment of case e.g. medical history, family history, test results.      |

| |

| |

| |

| |

| |

Signature of person making report:_________________________Date:____/____/____ Cont. next page

Name (please print):_____________________________ Job title:__________________________

|Signature of Chief /Principal Investigator or delegated physician: | |

|Name (print please):       |

|I confirm that the contents of this form (pages 1± 2/3) are accurate and complete |

Appendix 4

|R&D use only: case reference number | |

|To be completed by the person filling in the SAE form |

|SUHT R&D number: |RHM       |Subject ID/initials |      |Onset date of SAE |      |

FORM 3 - RESEARCH RELATED SAE/SUSAR FOLLOW UP REPORT FORM (Page 2 of 3)

Sheet number: of

|4. CONCOMITANT MEDICATION – details of administration of other medication concurrent with the IMP(s)/device/intervention. |

|Brand name: |Indication |Route |Form |Total dose/24h |Regimen (e.g. BD) |Start date |Stop date |Or duration of treatment|

| | |(e.g. oral) |(e.g. tablet) |(specify units) | |& time |& time | |

|      |      |      |      |      |      |      |      |      |

|      |      |      |      |      |      |      |      |      |

|      |      |      |      |      |      |      |      |      |

|      |      |      |      |      |      |      |      |      |

|      |      |      |      |      |      |      |      |      |

|      |      |      |      |      |      |      |      |      |

Continue on new sheet if necessary; please identify how many sheets have been used.

Signature of person making report:_________________________Date:____/____/____ Cont. next page

Appendix 4

|R&D use only: case reference number | |

|To be completed by the person filling in the SAE form |

|SUHT R&D number: |RHM       |Subject ID/initials |      |Onset date of SAE |      |

FORM 3 - RESEARCH RELATED SAE/SUSAR FOLLOW UP REPORT FORM (Page 3 of 3)

Sheet number: of

|5. STUDY IMP – details of administration. NB complete for IMP studies only |

|Brand name: |Indication|Batch no. |Route |Form |

| | | |(e.g. |(e.g. tablet) |

| | | |oral) | |

|*If yes, give details:      |

Continue on new sheet if necessary; please identify how many sheets have been used.

Name of person completing report:

Signature of person making report:________________________________Date:____/____/____

Page 1 of 1

FORM 4 - SAE/SUSAR SPONSOR REPORT FORM

|This page for R&D Use Only |

|SUHT sponsored/Co-sponsored Studies |

|Case reference number |      |

|SUHT R&D No: |RHM       |

|EudraCT No (IMP trials only): |      |

|1. Sponsor assessment of causality |

| |*If possibly, probably or definitely related, was|1 - Ensure all required sections of the follow up |

|Is the SAE related to the |the SAE unexpected? |report form have been completed. |

|drug/device/intervention? |Yes1 | |

|Not related |No2 |2 - Ensure sections 1, 2 and 3 of the follow up report |

|Unlikely to be related | |form have been completed. |

|Possibly related* |(Unexpected means not described in the protocol | |

|Probably related* |or other product information) | |

|Definitely related* | | |

|Comments:       |

|Name of person performing sponsor assessment[1]: |Contact Number: |

|      |      |

|Signature of person performing sponsor assessment: |Date: |

|      |      |

|2. Administrative and sponsor details |

|Date report received from investigator: |CTA/DDX number (if applicable): |

|      |      |

|Name and Address of sponsor: |Contact person at Sponsor |

| | |

|Southampton University Hospitals Trust |Name:       |

|R&D Department | |

|Duthie Building (Trust) |Address: Same as sponsor. |

|Ground Floor | |

|MP 138 | |

|Southampton General Hospital | |

|Tremona Road |Telephone no: 023 8077 4245 |

|Southampton |Fax no: 023 8079 8678 |

|Hants SO16 6YD | |

FORM 5- ANNUAL SAFETY REPORT FORM - IMP STUDIES – SUHT SPONSOR/CO-SPONSOR

Instructions for Researchers

1. Six-monthly Safety Reports

1. 6-monthly safety reports are only required for IMP studies where a commercial sponsor is responsible for non-UK sites. The 6-monthly report does not apply for SUHT sponsored or SUHT-Co-sponsored clinical trials.

1. Annual Safety Reports

1. One year following the granting of a Clinical Trials Authorisation Certificate, and thereafter annually , complete sections 1-5 of the Annual Safety Report Form - IMP Studies – SUHT Sponsor/Co-sponsor.

2. In addition, complete Safety Report form for CTIMPs available at:

3. If there have been no reports of any SSARs:

Cross through section 5 and mark as not required. Sign and date comment.

Post the completed Annual Safety Report forms as electronic documents to:

▪ Information Processing Unit, Area 6, Medicines & Healthcare products Regulatory Agency (MHRA), Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ.

Post the Annual Safety Report as paper copies to:

▪ The REC that granted approval (NB An annual progress report will also be required).

▪ SUHT R&D Department, R&D Office, Duthie Building (Trust), Ground Floor, MP 138, SGH, Tremona Road, Southampton, Hants, SO16 6YD, (NB An annual progress report will also be required).

4. If SAEs have been reported during the study and an unblinded assessment was performed by R&D, send part completed forms to the R&D Department, Duthie Building (Trust), Ground Floor, MP 138, SGH, Tremona Road, Southampton, Hants, SO16 6YD

2. Instructions for R&D Department

1. On receipt of a part-completed Annual Report Form, R&D complete Section 5 ‘Causality’ and ‘Expectedness’ columns for all SUSARs/SSARs reported to the SUHT and where an unblinded assessment has been performed by the SUHT R&D.

2. Insert details of R&D person making the report on bottom of page

3. R&D then keeps a copy of the Annual Safety Report (unblended) confidentially in the R&D file and posts a CD-Rom/USB stick with e-version of Annual Safety Report to:

Information Processing Unit,

Area 6,

Medicines & Healthcare products Regulatory Agency,

Market Towers,

1 Nine Elms Lane,

London

SW8 5NQ

4. Inform CI that Annual Safety Report was posted. NB Do not provide the CI with any information that could unblind and compromise the study.

FORM 5- ANNUAL SAFETY REPORT FORM - IMP STUDIES – SUHT SPONSOR/CO-SPONSOR

Covering period from (mmm/yyyy): _______________ to ______________

Page 1 of --

|1. Details of Sponsor |

|Organisation: |      |

|Name of person to contact: |      |

|Contact address: |      |

|Email address: |      |

|Telephone No: |      |

|Fax number: |      |

|2. Details of person making report (if different to above) |

|Name: |      |

|Job title/role in study: |      |

|Contact address: |      |

|Email address: |      |

|Telephone No: |      |

|Fax number: |      |

|3. Details of study |

|SUHT R&D No: |RHM      |Ethics No: |      |

|EudraCT No: |      |CTA No: |      |

| | |(If CTA not yet issued, DDX no.) | |

|Full Title of Study:       |

| |

| |

| |

| |

| |

|Date of MHRA approval: |      |

|4. Summary of Serious Adverse Events (SAEs) |

|Number of SAEs |In reporting year:       |In total:       |

|No. of SSARs |In reporting year:       |In total:       |

|No. of SUSARs |In reporting year:       |In total:       |

Signature of person making report:_________________________Date:____/____/____ Cont. next page

|SUHT R&D No: |RHM       |Ethics No: |      |

|EudraCT No: |      |CTA No: |      |

| | |(If CTA not yet issued, DDX no.) | |

FORM 5- ANNUAL SAFETY REPORT FORM - IMP STUDIES – SUHT SPONSOR/CO-SPONSOR

Page 2 of ----

|4. Report on subjects’ safety in CTIMP |

|Are there any new findings[2] related to the safety of the IMP treatments in |Yes |No |

|this trial? | | |

|If yes, provide details[3]:       |

| |

| |

| |

| |

|Have there been any other experiences with this IMP that could affect the |Yes |No |

|subjects’ safety? | | |

|If yes, provide details[4]:       |

| |

| |

| |

| |

| |

|Is it necessary to amend the protocol, patient information sheet, consent |Yes |No |

|form or investigator brochure? | | |

|If yes, give details and rationale:       |

| |

| |

| |

| |

| |

Signature of person making report:_________________________Date:____/____/____ Cont. next page

|SUHT R&D No: RHM       |Ethics No:       |EudraCT No:       |CTA No (If CTA not yet issued, DDX no.):       |

FORM 5- ANNUAL SAFETY REPORT FORM - IMP STUDIES – SUHT SPONSOR/CO-SPONSOR

Continue on new sheet if necessary; please identify how many sheets have been used Page --------- of

|5. Line listing of Suspected Serious Adverse Reactions (SSARs) |

| |Details of IMP(s) list all |Details of SSAR | |

| | | | | | | | | | | | | | |Study Subject Id |AE No.

|Country |Age |Sex |Name of IMP |Dose |Route |Date of onset[5] |Dates of IMP treatment[6] |Description of adverse event |Outcome |Causality[7]

|Expected[8]

(Yes/No) | |      |      |      |      |      |      |      |      |      |      |      |      |      |      | |      |      |      |      |      |      |      |      |      |      |      |      |      |      | |      |      |      |      |      |      |      |      |      |      |      |      |      |      | |      |      |      |      |      |      |      |      |      |      |      |      |      |      | |      |      |      |      |      |      |      |      |      |      |      |      |      |      | |

Signature of person making report:_________________________Date:____/____/____

Signature of R&D person completing report (if applicable):________________________________Date:____/____/___

-----------------------

[1] Where the assessment has been performed by the Data Safety Monitoring Board, give the name of the Chair and attach a list of names of the members of the Board who participated in the assessment.

[2] New findings refers to information not already present in the Investigator’s Brochure or for licensed drugs the Summary of Product Characteristics (SmPC).

[3] When relevant, the following points should be considered: relation with dose, duration, time course of the treatment; reversibility; evidence of previously unidentified toxicity in the trial subjects; increased frequency of toxicity; overdose and its treatment; interactions or other associated risks factors; any specific safety issues related to special populations, such as the elderly, the children or any other at risk groups; positive and negative experiences during pregnancy or lactation; abuse; risks which might be associated with the investigation or diagnostic procedures of the clinical trial.

[4] When relevant, the following points should be considered: relation with dose, duration, time course of the treatment; reversibility; evidence of previously unidentified toxicity in the trial subjects; increased frequency of toxicity; overdose and its treatment; interactions or other associated risks factors; any specific safety issues related to special populations, such as the elderly, the children or any other at risk groups; positive and negative experiences during pregnancy or lactation; abuse; risks which might be associated with the investigation or diagnostic procedures of the clinical trial.

[5] If not available, best estimate of time to onset and route of administration. For an ADR known to occur after cessation of therapy, estimate of time lag if possible.

[6] If not available, best estimate of treatment duration

[7] Possibly, probably or definitely related. Only required where sponsor assessment differs from investigator assessment

[8] Results of unblinded assessment with reference documentation (e.g. investigator brochure, summary of product characteristics). For blinded studies where the research team are all blinded this information should be completed last by SUHT R&D Department and the report sent directly to the main REC and MHRA. Unless required for safety reasons this information must not be provided to blinded investigators.

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