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General Observations and Comments (Day 1

)
Board Meeting
Good


points
There is quorum (complete attendance of the members)
The Conflict of Interest was addressed
They reviewed the Minutes of the Meeting
 Recommendation: Need to put pertinent information in the agenda
 Recommendation: Issues in the protocol should be included on the next
Minutes of the meeting
 For the Protocol: “Prevalence and risk factors of atopic dermatitis...”
 Provision of the report – referring the case to treat other diseases
 Generally, they were able to catch the issue
 For the Protocol: “Piroxicam Transderm patch in the Management...”
 They were able to identify the key issues in the protocol
 For the 2 Protocols regarding the use of MK-3102:
1) “To Assess Cardiovascular Outcomes...”; and 2) “To Assess the safety and
Efficacy...”
 They were able to grasp the key issues regarding the deviations and
notifications

Weak Points






No definition of quorum in the SOP
There is only one Non-Institutional Lay Member
 Recommendation: Need one more non-affiliated member
Are the members of MMERC are staff or visiting consultants? What is their
affiliation, ManilaMed or UPM? Who are really affiliated only in ManilaMed?
No recommendation regarding the issues identified in the protocols
No voice recording of the minutes
There were times that the Staff Secretary is out of the meeting and no one
taking down the minutes
The difference of the Protocol Numbering System. Why the numbers are the
same? The only difference is the letter (e.g. “R” for Residents, “T” for
Transferred, and No assigned letter for Directly submitted protocols)
 Recommendation: Clarify the number of protocols; Needs to be in
sequential order and only one series per year
Is the Protocol Numbering System being used consistent in the SOP re:
Documentation and Archiving?

For the Protocol: “Prevalence and risk factors of atopic dermatitis...”
 Check the appointment of Dr. Clarita Maaño as the independent
consultant
 Technical Issue/s:
 What tool/questionnaire to be used in the study?
 Is there a literature review?

.            Data stating prevalence on Children?  Is the age group appropriate? Methodology issue/s:  Will they only use the questionnaire to identify the prevalence or will they examine the patient in person?  Risk Factor: Is there a standard questionnaire?  (Confusion) If you only want to see the Prevalence and Risk Factors.. you are only counting the number and you won’t test the validity of the study \ Ethical Issue/s:  The possibility of stigma (confusion with psoriasis and other diseases)  Issue on the Assent Form Difference between prevalence and quality of life? It should not be classified as a clinical trial There is no definition/description of Atopic dermatitis  CHECK the protocol Statistical Problem:  Define the household respondents that will be included in the study  CHECK THE PROTOCOL Is there a need of a GCP training for the Co-investigator? The use of the word: “Influential”  You actually get consent from the community leader  Needs clarification/correction of the word There should be 2 levels of consent  From the Political Unit/Leadership  From the household respondents involved There is no over-all summary of the protocol reviewed MMERC Decision: Major Modification  CHECK the difference of Major Modification and Minor Modification For the protocol: “Piroxicam Transderm patch in the Management..”  Confusing study design  Is it placebo?  Are they comparing the same thing/drugs?  Are they testing the route/way of administering the drugs?  There is no discussion of possible SAEs in the study  No provision of adverse events  The PI should report SAEs  Recommendation: Look at the possibility of SAEs  The literature used is too old  No over-all summary  Decision: Major Modification  How do they identify major from minor modification? For the protocol: “Lumbar Stimulation And Suprapubic Tapping Technique..” .

..”  Issues regarding the Principal Investigator (PI)  It is not appropriate to get a Cardiologist as a PI on (A).”  (B)“To Assess Cardiovascular Outcomes Following Treatment. You need an endocrinologist  Need to ask why does he have a lot of deviations from the protocol  ERC should send a letter informing the PI regarding this matter  Possible actions of ERC:  Ask the sponsor to determine whether the patient/s should stay in the study  Address the violations/deviations  Exclusion Criteria  The study started with the laboratory procedure without the updated ICF  Recommendation: They need to establish how they will identify patterns in protocol deviations and other problems  For the Protocol (B):  What is the consequence to the safety of the patient  One who reconsented  One who already withdrew from the study but there’s no proper documentation  Recommendation: Improve methodologies OFFICE  Resources are shared with other departments  No Internet-based capacity/back-up  They have MS Word database (of the protocol summary only)  No logbooks of incoming and outgoing documents  No Flowchart or posters explaining ERC procedures  No website for the free-access of the SOPs  Recommendations:  The database should be in MS excel  They should have at least a printer/scanner  For the Staff Secretary: Determine if she can still do the job if she’s also handling 17 other committees  They should have a separate USB/Flash disk for the back-up files  Address COI of the members/staff .. The video and other documents that will be utilized in the study should be properly documented  Need to show/evaluate the video by the ERC  The primary reviewer should have appropriate judgment regarding the issues  What kind of tapping technique will be applied using the video?  It needs approval of the ERC members during the Board meeting  Differences in the opinions of the ERC members  No consensus regarding whether the video will be used or not For the protocol utilizing MK-3102 in two different studies  (A)“To Assess the Safety and efficacy of MK-3102 in Subjects with Type 2 Diabetes..

etc. inactive. ERC members should not be also involved in the study as PI  They need to harmonize the protocols.  There should be a proper inventory of the Clinical Trial that are still active form the Transferred Protocols from EAC Note: ERC needs 1 Full Time staff for every 100 For initial review Protocols Challenges of ERC  The Member Secretary is overwhelmed o Needs advanced GCP training since she’s primary responsible whether a protocol will undergo Expedited or Full Board Review  They are still trying to learn/grasp the idea  Only the ERC Chair has training on SOPs o Members should have Continuing Training as stated in the SOP . better filing of the protocol  Check the definition of active study.