National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Metabolomics analysis of colitis associated colorectal cancer patients via GC-MS

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

English title:
- write with a hyphen: colitis-associated
- the abbreviation should be preceded by the full name (gas chromatography-mass spectrometry)
Arabic title:
- يتم كتابة اسم الجهاز باللغة العربية
Scientific Degree: Others
- Please explain
Research site and Approval: NRC
- You stated later on that the patients will be recruited from Kasr Alaini Hospital (Cairo University). This point is not clear. Please, explain
Study Type: Other
- Please explain what the type of study is
Select Date: 2025-02-01
- This date is not applicable because it must be a date after the expected date of obtaining the Ethics approval.
The protocol was reviewed by scientific reviewing committee. No
- The signed Form 90 (by the head of your department) means that the proposal had scientific approval by an internal scientific reviewing committee at your department.
Research Team Information and the process he/ she is responsible
- The team does not include members from “the Internal Medicine Department” of Kasr Alaini Hospital who shared in clinical diagnosis or shared in collection of blood samples.
Exclusion criteria: Any cancer other than HCC.
- CRC
Explain how you calculated the sample size. Pilot Study
- Please explain the calculation method or reference
The age range of participants: 20-60 years old, BUT in inclusion criteria, the age was above 18
- please, unify your age range all over the application

Locality of recruited population: Internal Medicine Department of Kasr El Aini Hospital.
- Is there an ethics consent from Kasr Alaini Hospital?
Recruitment procedure Exclusion criteria: 1- Any cancer other than HCC.
- Please, correct type of cancer
Negative outcome: an assurance that the results will be made available, as appropriate, through publication or by reporting to local ethics committee and the Egyptian Drug Administration: Yes
- Is this answer a negative outcome? And is there a need to report to the Egyptian Drug Administration?

ملف تعهد و إقرا ر بالحفاظ علي سياسة تضارب المصالح
- برجاء تنزيل هذا الملف من على الموقع وقراءته جيدا ثم التوقيع على التعهد الموجود في هذا الملف كما جاء في تعليقات المراجعة الفنية

ملف الموافقة المستنيرة غير كامل ويشمل الصفحة الأخيرة والصفحة الأولى فقط و لم يتم حذف العبارات الإرشادية منه..
لذا يرجى من الباحث تنزيل النماذج الجديدة التي وفرتها اللجنة وهي أولا: نموذج الموافقة المستنيرة الذي به تعليقات جانبية لإرشادات الكتابة الصحيحة و ثانيا: ملف شرح لكيفية كتابة الموافقة المستنيرة
ثم يقوم بتحميل نموذج الموافقة المستنيرة كاملا بعد تصحيح صياغته حسب الإرشادات

Comment to the Committee

Informed consent form:

Needs Modification

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