http://www.100md.com
中医循证医学
INSTRUCTIONS TO INVESTIGATORS ON DETECTION, EVALUATION,REPORTING AND MEDICAL MANAGEMENT OF AE AND SAE
Detection and Evaluation
· Information about all AEs, whether volunteered by the patient, discovered by investigator questioning or detected through physical examination, laboratory test or other means, will be recorded on the Adverse Event Page of the CRF and followed as appropriate.
, http://www.100md.com
· When eliciting experiences of AE from subject, ask a standard non-leading question “Do you feel different in any way since starting the new treatment/the last visit?”.. This question will be put to patient in his/her own language at each study visit.
· All adverse events (AE) must be recorded in Adverse Event (AE) page of CRF. Complete all columns for each adverse event.
· Enter the code provided in column header for classification of AE.
, 百拇医药
· Evaluate AE as follows:
, http://www.100md.com
SERIOUS ADVERSE EVENTS
· All serious adverse event (SAE) must be recorded in Serious Adverse Event (SAE) page of CRF.
· SAE must be reported to CRC by phone or fax with the Serious Adverse Event (SAE) page of CRF within 24 hours. Ssee below for contact persons and numbers.
· Investigator should not wait to receive additional information to fully document the SAE before notifying CRC. Telephone report of SAE should be followed by a full written summary detailing relevant aspects of the SAE in question. Where applicable, information from relevant medical records and autopsy reports should be obtained.
, http://www.100md.com
· Where required, the investigators must also inform the IRB/IEC of any SAEs.
Complete SAE CRF as follows:
· Record AE No. which should correspond to the number recorded in Adverse Event (AE) page of CRF.
· Start Date: Date when SAE began.
· Stop Date: Date when SAE stopped.
· If death occurred, specify the date of death.
, http://www.100md.com
· Describe the SAE in ‘Description of Serious Adverse Event’..
Treatment and Follow up of AE
, 百拇医药
Treatment of any AE is at the sole discretion of the investigator.
Refer Appendix E of protocol for detailed guideline to be used for the management of AE related to study treatment.
Investigators should follow-up subjects with AE until the event has resolved (subject recovered) or until the condition has stabilised. Otherwise, appropriate medical care should be arranged for the patient.
, 百拇医药
Abnormal test results should be repeated until return to baseline levels.
Any follow-up information should be reported to CRC monitor as soon as the relevant information becomes available
Safety Update
Sponsor will notify investigators of all AEs that are serious or unexpected, and very likely, probably or possibly related to the investigational product.
, http://www.100md.com
The notification will be in the form of a Safety Update to the Investigator Brochure.
Upon receiving such notices, the investigator must review and retain the notice with the Investigator brochure and immediately submit a copy of this information to the IRB/IEC where required. The IRB/IEC will determine if the informed consent requires revision. The investigator should also comply with the IRB/IEC procedures for reporting any other safety information. , 百拇医药
Detection and Evaluation
· Information about all AEs, whether volunteered by the patient, discovered by investigator questioning or detected through physical examination, laboratory test or other means, will be recorded on the Adverse Event Page of the CRF and followed as appropriate.
, http://www.100md.com
· When eliciting experiences of AE from subject, ask a standard non-leading question “Do you feel different in any way since starting the new treatment/the last visit?”.. This question will be put to patient in his/her own language at each study visit.
· All adverse events (AE) must be recorded in Adverse Event (AE) page of CRF. Complete all columns for each adverse event.
· Enter the code provided in column header for classification of AE.
, 百拇医药
· Evaluate AE as follows:
| BLOCK ON AE CRF | INSTRUCTIONS |
| AE No. | Each AE will be assigned a number. Assign the number started from 1. |
| Description of Clinical AE | Documented in terms of a medical diagnosis (es). When this is not possible, the AE should be documented in terms of signs and/or symptoms observed by the investigator or reported by the subject. |
| Onset Date | Date when AE began. Any changes to AE parameters require new onset date. |
| AE Stop Date or Check Box if Continuing | Enter date symptoms stopped. If AE is still present, check the box for continuing. |
| Severity | |
| 1= Mild | Awareness of signs or symptoms, but they are easily tolerated. |
| 2= Moderate | Enough discomfort to cause inteference with usual activity. |
| 3= Severe | Incapacitating, with inability to work or to do usual activity. |
| 4= Life Threatening | Subject at risk of death at the time of event. |
| Note that a severe AE is not necessarily serious. The term severe is a measure of the intensity while a serious AE is determined based on regulatory criteria. , http://www.100md.com A life threatening AE is an SAE | |
| Action taken | |
| 1= None | No action taken. |
| 2= Reduce dose | Dose of study medication reduced. |
| 3= Discontinued Temporarily | Study treatment stopped but after subject’s symptoms abated, the subject was rechallenged with study treatment |
| 4= Discontinued permanently | Study treatment was permanently stopped |
| 5= Specific treatment | Specific treatment or procedure instituted for the AE. |
| 6= Other actions | For example, hospitalsation |
| Relationship | The degree of certainty with which an AE is attributed to study treatment or alternative cause like natural history of disease or concomitant treatment should be guided by the following considerations: , 百拇医药 · Time relationship between treatment and occurrence of AE · Known pharmacology of drug · Reaction of similar nature being previously observed with this drug or class of drug · Reaction having often been reported in literature for similar drug as drug related eg. skin rashes, blood dyscrasia |
| 1= Very likely | · The adverse event follows a reasonable temporal sequence from study treatment administration , 百拇医药 · Abates upon discontinuation of study treatment · Reappears on repeat exposure (rechallenge) |
| 2= Probably | · The adverse event follows a reasonable temporal sequence from study treatment administration · Abates upon discontinuation of study treatment · Cannot reasonably be explained by known characteristics of the subject’s clinical state. |
| 3= Possibly | · The adverse event follows a reasonable temporal sequence from study treatment administration , http://www.100md.com · But could have been produced by the subject’s clinical state or other mode of therapy administered to the subject |
| 4= Remote or doubtful | · The temporal association between study treatment and adverse event is such that the study treatment is not likely to have any reasonable association with the observed event |
| 5= Very Unlikely | · The adverse event is definitely produced by the subject’s clinical state or other mode of therapy administered to the subject |
| Outcome to Date | |
| 1= Recovered | The subject has fully recovered from the adverse event with no residual effect observable |
| 2= Recovered with Sequelae | Residual effects of the adverse event are still present and observable. |
| 3= Ongoing at Subject Study | The adverse event is still present and observable at study conclusion for the subject |
| 4= Died | Died. Fill in the SAE page of CRF. |
| 5= Unknown | Data unknown |
| Check if AE is serious | Check the box if the AE is serious. If the box is checked, complete the SAE page of CRF. |
| Date lab specimen obtained or special exam performed | Enter the date of the laboratory exam or special safety exam on which the AE was noted. |
, http://www.100md.com
SERIOUS ADVERSE EVENTS
· All serious adverse event (SAE) must be recorded in Serious Adverse Event (SAE) page of CRF.
· SAE must be reported to CRC by phone or fax with the Serious Adverse Event (SAE) page of CRF within 24 hours. Ssee below for contact persons and numbers.
· Investigator should not wait to receive additional information to fully document the SAE before notifying CRC. Telephone report of SAE should be followed by a full written summary detailing relevant aspects of the SAE in question. Where applicable, information from relevant medical records and autopsy reports should be obtained.
, http://www.100md.com
· Where required, the investigators must also inform the IRB/IEC of any SAEs.
Complete SAE CRF as follows:
· Record AE No. which should correspond to the number recorded in Adverse Event (AE) page of CRF.
· Start Date: Date when SAE began.
· Stop Date: Date when SAE stopped.
· If death occurred, specify the date of death.
, http://www.100md.com
· Describe the SAE in ‘Description of Serious Adverse Event’..
| Study Contact for Reporting Serious Adverse Events |
| Mr. XYZ Clinical Research Centre Kuala Lumpur Hospital 50586 Kuala Lumpur Malaysia , http://www.100md.com Tel: ##### Fax: ##### E-mail: #####After Office hours: Mobile phone: Home phone: |
| Back-up Study Contact for Reporting Serious Adverse Events |
| Mr. ABC Tel: ##### Fax: ##### |
Treatment and Follow up of AE
, 百拇医药
Treatment of any AE is at the sole discretion of the investigator.
Refer Appendix E of protocol for detailed guideline to be used for the management of AE related to study treatment.
Investigators should follow-up subjects with AE until the event has resolved (subject recovered) or until the condition has stabilised. Otherwise, appropriate medical care should be arranged for the patient.
, 百拇医药
Abnormal test results should be repeated until return to baseline levels.
Any follow-up information should be reported to CRC monitor as soon as the relevant information becomes available
Safety Update
Sponsor will notify investigators of all AEs that are serious or unexpected, and very likely, probably or possibly related to the investigational product.
, http://www.100md.com
The notification will be in the form of a Safety Update to the Investigator Brochure.
Upon receiving such notices, the investigator must review and retain the notice with the Investigator brochure and immediately submit a copy of this information to the IRB/IEC where required. The IRB/IEC will determine if the informed consent requires revision. The investigator should also comply with the IRB/IEC procedures for reporting any other safety information. , 百拇医药