Dear Members;

I wish you are all fine. Firstly: Happy mother's day, it is great to celebrate with all mothers who are alive-God bless them- and to always remember whom passed away- God rest their souls-

·         All documents that Isabelle asked about are written in the guidelines of WHO, again the most important thing is to prepare our SOPs or disclose that we follow for example :WHO guidelines as our REC at FOM-SCU

·         Concerning that one REC could rely on the reviewing of others, I think it is not suitable at that time because we build our experience and it is a cumulative one which is directly propositional to the number of research proposals we review. If for example FOMSCU depends on Ain Shams'REC, there will be a discrepancy in our competence. Another thing is that each site is aware of all surrounding situations

·          Regarding Transfer of biological samples, I agree with Shams's opinion

I have an inquiry: in case of multi-center clinical trials what will happen if one of the sites asks for modifications in the protocol that has been already approved by the other sites?

Best regards,

Nahed

From: inakhla1 <inakhla@...>
Subject: [EGYPTIAN_RECS] Still review of multi-site research
To: EGYPTIAN_RECS@yahoogroups.com
Date: Thursday, March 19, 2009, 10:44 PM

Dear members
Thank you very much for the discussions over the last two weeks. I would like to ask you what do you think about including in addition to the original protocol of the sponsor, an adendum detailing such information as:
- Who will be study team members in the local site
- Where and how are the participants to be recruited
- Description of the population targeted and their vulnerabilities, if applicable
- Description of the study site
In other words, a summary of the protocol pertaining to the local site in what concern the specific details only.

Also, would you like to see a copy of the sponsor's approval and that of other IRBs of the protocol?

As for the topic of relying of one IRB on the review of another one, I could sense that the members agree that this is an idea to consider, but in the future, and not for the time being.

The material transfer agreement was mentioned during the discussions, and the field is open to discuss it now!

I have another related question to raise that might appear naive, but we need to think about it deeper:
Why do we fear the transfer of samples from one country to the other?

Hoping to hear from all of you, best wishes for a happy weekend,

Isabelle